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POTENZA Handpiece

Model AC Handpiece · Jeisys Medical Inc. · DI 08800020101754

GEI — Electrosurgical, Cutting & Coagulation & Accessories · Class II · 21 CFR 878.4400

UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

23572019-01: 0 reports for this device; peer average 6.86/device2019-02: 0 reports for this device; peer average 4.35/device2019-03: 0 reports for this device; peer average 4.42/device2019-04: 0 reports for this device; peer average 6.12/device2019-05: 0 reports for this device; peer average 4.8/device2019-06: 0 reports for this device; peer average 5.04/device2019-07: 0 reports for this device; peer average 5.86/device2019-08: 0 reports for this device; peer average 6.1/device2019-09: 0 reports for this device; peer average 4.99/device2019-10: 0 reports for this device; peer average 5.85/device2019-11: 0 reports for this device; peer average 5.62/device2019-12: 0 reports for this device; peer average 5.41/device2020-01: 0 reports for this device; peer average 4.81/device2020-02: 0 reports for this device; peer average 5.57/device2020-03: 0 reports for this device; peer average 5.68/device2020-04: 0 reports for this device; peer average 3.57/device2020-05: 0 reports for this device; peer average 3.76/device2020-06: 0 reports for this device; peer average 5.14/device2020-07: 0 reports for this device; peer average 6.56/device2020-08: 0 reports for this device; peer average 4.64/device2020-09: 0 reports for this device; peer average 5.86/device2020-10: 0 reports for this device; peer average 5.55/device2020-11: 0 reports for this device; peer average 5.14/device2020-12: 0 reports for this device; peer average 5.31/device2021-01: 0 reports for this device; peer average 5.17/device2021-02: 0 reports for this device; peer average 4.89/device2021-03: 0 reports for this device; peer average 5.7/device2021-04: 0 reports for this device; peer average 5.26/device2021-05: 0 reports for this device; peer average 5.14/device2021-06: 0 reports for this device; peer average 5.83/device2021-07: 0 reports for this device; peer average 4.89/device2021-08: 0 reports for this device; peer average 4.3/device2021-09: 0 reports for this device; peer average 4.77/device2021-10: 0 reports for this device; peer average 6.17/device2021-11: 0 reports for this device; peer average 5.57/device2021-12: 0 reports for this device; peer average 5.56/device2022-01: 0 reports for this device; peer average 5.04/device2022-02: 0 reports for this device; peer average 5.15/device2022-03: 0 reports for this device; peer average 5.75/device2022-04: 0 reports for this device; peer average 4.98/device2022-05: 0 reports for this device; peer average 5.78/device2022-06: 0 reports for this device; peer average 6.3/device2022-07: 0 reports for this device; peer average 4.36/device2022-08: 0 reports for this device; peer average 4.59/device2022-09: 0 reports for this device; peer average 5/device2022-10: 0 reports for this device; peer average 4.76/device2022-11: 0 reports for this device; peer average 4.61/device2022-12: 0 reports for this device; peer average 4.04/device2023-01: 0 reports for this device; peer average 5.52/device2023-02: 0 reports for this device; peer average 4.59/device2023-03: 0 reports for this device; peer average 4.87/device2023-04: 0 reports for this device; peer average 4.78/device2023-05: 0 reports for this device; peer average 5.14/device2023-06: 0 reports for this device; peer average 4.78/device2023-07: 0 reports for this device; peer average 4.82/device2023-08: 0 reports for this device; peer average 4.44/device2023-09: 0 reports for this device; peer average 5.23/device2023-10: 0 reports for this device; peer average 5.1/device2023-11: 0 reports for this device; peer average 4.38/device2023-12: 0 reports for this device; peer average 4.79/device2024-01: 0 reports for this device; peer average 5.54/device2024-02: 0 reports for this device; peer average 5.46/device2024-03: 0 reports for this device; peer average 6.16/device2024-04: 0 reports for this device; peer average 6.04/device2024-05: 0 reports for this device; peer average 6.28/device2024-06: 0 reports for this device; peer average 5.39/device2024-07: 0 reports for this device; peer average 5.05/device2024-08: 0 reports for this device; peer average 5.01/device2024-09: 0 reports for this device; peer average 5.19/device2024-10: 0 reports for this device; peer average 5.7/device2024-11: 0 reports for this device; peer average 5.29/device2024-12: 0 reports for this device; peer average 4.06/device2025-01: 0 reports for this device; peer average 5.17/device2025-02: 0 reports for this device; peer average 4.46/device2025-03: 0 reports for this device; peer average 6.28/device2025-04: 0 reports for this device; peer average 4.39/device2025-05: 0 reports for this device; peer average 5.16/device2025-06: 0 reports for this device; peer average 5.08/device2025-07: 0 reports for this device; peer average 5.2/device2025-08: 0 reports for this device; peer average 5.45/device2025-09: 0 reports for this device; peer average 4.85/device2025-10: 0 reports for this device; peer average 5.14/device2025-11: 0 reports for this device; peer average 5.55/device2025-12: 0 reports for this device; peer average 5.81/device2026-01: 0 reports for this device; peer average 5.63/device2026-02: 0 reports for this device; peer average 5.98/device2026-03: 0 reports for this device; peer average 6.2/device2026-04: 0 reports for this device; peer average 5.43/device2026-05: 0 reports for this device; peer average 6.19/device2026-06: 0 reports for this device; peer average 5.56/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0106.86
2019-0204.35
2019-0304.42
2019-0406.12
2019-0504.8
2019-0605.04
2019-0705.86
2019-0806.1
2019-0904.99
2019-1005.85
2019-1105.62
2019-1205.41
2020-0104.81
2020-0205.57
2020-0305.68
2020-0403.57
2020-0503.76
2020-0605.14
2020-0706.56
2020-0804.64
2020-0905.86
2020-1005.55
2020-1105.14
2020-1205.31
2021-0105.17
2021-0204.89
2021-0305.7
2021-0405.26
2021-0505.14
2021-0605.83
2021-0704.89
2021-0804.3
2021-0904.77
2021-1006.17
2021-1105.57
2021-1205.56
2022-0105.04
2022-0205.15
2022-0305.75
2022-0404.98
2022-0505.78
2022-0606.3
2022-0704.36
2022-0804.59
2022-0905
2022-1004.76
2022-1104.61
2022-1204.04
2023-0105.52
2023-0204.59
2023-0304.87
2023-0404.78
2023-0505.14
2023-0604.78
2023-0704.82
2023-0804.44
2023-0905.23
2023-1005.1
2023-1104.38
2023-1204.79
2024-0105.54
2024-0205.46
2024-0306.16
2024-0406.04
2024-0506.28
2024-0605.39
2024-0705.05
2024-0805.01
2024-0905.19
2024-1005.7
2024-1105.29
2024-1204.06
2025-0105.17
2025-0204.46
2025-0306.28
2025-0404.39
2025-0505.16
2025-0605.08
2025-0705.2
2025-0805.45
2025-0904.85
2025-1005.14
2025-1105.55
2025-1205.81
2026-0105.63
2026-0205.98
2026-0306.2
2026-0405.43
2026-0506.19
2026-0605.56
This device (reports/month)Average device in GEI (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K192545 — cites (transitively): K092761 (d1), K153727 (d1), K160469 (d1), K170325 (d1), K180189 (d1), K121481 (d2), K102372 (d2), K881276 (d2), K160312 (d2), K081365 (d2), K082451 (d2), K102461 (d2), K130501 (d2), K142438 (d2), K151019 (d2), K151273 (d2), K002002 (d3), K030362 (d3), K861036 (d3), K073572 (d3), K083461 (d3), K101510 (d3), K073227 (d3), K073229 (d3), K132373 (d3), K140400 (d3), K121302 (d3), K140926 (d3), K123573 (d3), K063001 (d4), K072159 (d4), K080496 (d4), K091115 (d4), K103128 (d4), K123589 (d4), K122845 (d4), K123307 (d4), K014165 (d5), K031003 (d5), K050325 (d5), K062549 (d5), K062996 (d5), K063729 (d5), K992869 (d5), K102235 (d5), K050438 (d5), K122742 (d5), K061113 (d5), K971214 (d5), K002858 (d6), K013823 (d6), K043473 (d6), K063428 (d6), K951725 (d6), K033621 (d6) — cited as predicate by K201685, K203728, K221574, K222958, K241832

K201685 — cites (transitively): K092761 (d1), K192545 (d1), K153727 (d2), K160469 (d2), K170325 (d2), K180189 (d2), K121481 (d3), K102372 (d3), K881276 (d3), K160312 (d3), K081365 (d3), K082451 (d3), K102461 (d3), K130501 (d3), K142438 (d3), K151019 (d3), K151273 (d3), K002002 (d4), K030362 (d4), K861036 (d4), K073572 (d4), K083461 (d4), K101510 (d4), K073227 (d4), K073229 (d4), K132373 (d4), K140400 (d4), K121302 (d4), K140926 (d4), K123573 (d4), K063001 (d5), K072159 (d5), K080496 (d5), K091115 (d5), K103128 (d5), K123589 (d5), K122845 (d5), K123307 (d5), K014165 (d6), K031003 (d6), K050325 (d6), K062549 (d6), K062996 (d6), K063729 (d6), K992869 (d6), K102235 (d6), K050438 (d6), K122742 (d6), K061113 (d6), K971214 (d6), K002858 (d7), K013823 (d7), K043473 (d7), K063428 (d7), K951725 (d7), K033621 (d7) — cited as predicate by K210084, K230663, K231216, K231287, K243176, K250065

K231216 — cites (transitively): K201685 (d1), K092761 (d2), K192545 (d2), K153727 (d3), K160469 (d3), K170325 (d3), K180189 (d3), K121481 (d4), K102372 (d4), K881276 (d4), K160312 (d4), K081365 (d4), K082451 (d4), K102461 (d4), K130501 (d4), K142438 (d4), K151019 (d4), K151273 (d4), K002002 (d5), K030362 (d5), K861036 (d5), K073572 (d5), K083461 (d5), K101510 (d5), K073227 (d5), K073229 (d5), K132373 (d5), K140400 (d5), K121302 (d5), K140926 (d5), K123573 (d5), K063001 (d6), K072159 (d6), K080496 (d6), K091115 (d6), K103128 (d6), K123589 (d6), K122845 (d6), K123307 (d6), K014165 (d7), K031003 (d7), K050325 (d7), K062549 (d7), K062996 (d7), K063729 (d7), K992869 (d7), K102235 (d7), K050438 (d7), K122742 (d7), K061113 (d7), K971214 (d7), K002858 (d8), K013823 (d8), K043473 (d8), K063428 (d8), K951725 (d8), K033621 (d8) — cited as predicate by K242469

K231287 — cites (transitively): K201685 (d1), K092761 (d2), K192545 (d2), K153727 (d3), K160469 (d3), K170325 (d3), K180189 (d3), K121481 (d4), K102372 (d4), K881276 (d4), K160312 (d4), K081365 (d4), K082451 (d4), K102461 (d4), K130501 (d4), K142438 (d4), K151019 (d4), K151273 (d4), K002002 (d5), K030362 (d5), K861036 (d5), K073572 (d5), K083461 (d5), K101510 (d5), K073227 (d5), K073229 (d5), K132373 (d5), K140400 (d5), K121302 (d5), K140926 (d5), K123573 (d5), K063001 (d6), K072159 (d6), K080496 (d6), K091115 (d6), K103128 (d6), K123589 (d6), K122845 (d6), K123307 (d6), K014165 (d7), K031003 (d7), K050325 (d7), K062549 (d7), K062996 (d7), K063729 (d7), K992869 (d7), K102235 (d7), K050438 (d7), K122742 (d7), K061113 (d7), K971214 (d7), K002858 (d8), K013823 (d8), K043473 (d8), K063428 (d8), K951725 (d8), K033621 (d8)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Jeisys Medical Inc.

Nothing in the loaded window.