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4K UHD Laparoscope

Model 4K1030R · Scivita Medical Technology Co., Ltd. · DI 06971381250268

GCJ — Laparoscope, General & Plastic Surgery · Class II · 21 CFR 876.1500

HET — Laparoscope, Gynecologic (And Accessories) · Class II · 21 CFR 884.1720

NMH — Laparoscope And Accessories, Gynecologic, Reprocessed · Class II · 21 CFR 884.1720

UDILibrary device dossier · generated 2026-09-12 · 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.

4711142019-01: 0 reports for this device; peer average 2.43/device2019-02: 0 reports for this device; peer average 3.51/device2019-03: 0 reports for this device; peer average 2.93/device2019-04: 0 reports for this device; peer average 3.05/device2019-05: 0 reports for this device; peer average 2.43/device2019-06: 0 reports for this device; peer average 3.47/device2019-07: 0 reports for this device; peer average 2.39/device2019-08: 0 reports for this device; peer average 2.46/device2019-09: 0 reports for this device; peer average 2.44/device2019-10: 0 reports for this device; peer average 2.63/device2019-11: 0 reports for this device; peer average 2.09/device2019-12: 0 reports for this device; peer average 2.39/device2020-01: 0 reports for this device; peer average 2.52/device2020-02: 0 reports for this device; peer average 2.61/device2020-03: 0 reports for this device; peer average 2.29/device2020-04: 0 reports for this device; peer average 2.67/device2020-05: 0 reports for this device; peer average 2.07/device2020-06: 0 reports for this device; peer average 2.94/device2020-07: 0 reports for this device; peer average 2.97/device2020-08: 0 reports for this device; peer average 4.49/device2020-09: 0 reports for this device; peer average 4.48/device2020-10: 0 reports for this device; peer average 4.2/device2020-11: 0 reports for this device; peer average 4.89/device2020-12: 0 reports for this device; peer average 4.26/device2021-01: 0 reports for this device; peer average 4.25/device2021-02: 0 reports for this device; peer average 4.11/device2021-03: 0 reports for this device; peer average 5.32/device2021-04: 0 reports for this device; peer average 5.3/device2021-05: 0 reports for this device; peer average 4.65/device2021-06: 0 reports for this device; peer average 4.81/device2021-07: 0 reports for this device; peer average 4.16/device2021-08: 0 reports for this device; peer average 4.26/device2021-09: 0 reports for this device; peer average 4.34/device2021-10: 0 reports for this device; peer average 4.38/device2021-11: 0 reports for this device; peer average 3.77/device2021-12: 0 reports for this device; peer average 5.07/device2022-01: 0 reports for this device; peer average 5.65/device2022-02: 0 reports for this device; peer average 6.64/device2022-03: 0 reports for this device; peer average 6.91/device2022-04: 0 reports for this device; peer average 8.13/device2022-05: 0 reports for this device; peer average 6.75/device2022-06: 0 reports for this device; peer average 7.83/device2022-07: 0 reports for this device; peer average 8.06/device2022-08: 0 reports for this device; peer average 7.93/device2022-09: 0 reports for this device; peer average 6.85/device2022-10: 0 reports for this device; peer average 6.52/device2022-11: 0 reports for this device; peer average 6.9/device2022-12: 0 reports for this device; peer average 8.74/device2023-01: 0 reports for this device; peer average 8.38/device2023-02: 0 reports for this device; peer average 6.35/device2023-03: 0 reports for this device; peer average 8.43/device2023-04: 0 reports for this device; peer average 7.18/device2023-05: 0 reports for this device; peer average 7.55/device2023-06: 0 reports for this device; peer average 8.77/device2023-07: 0 reports for this device; peer average 7.75/device2023-08: 0 reports for this device; peer average 7.83/device2023-09: 0 reports for this device; peer average 7.85/device2023-10: 0 reports for this device; peer average 7.98/device2023-11: 0 reports for this device; peer average 7.67/device2023-12: 0 reports for this device; peer average 7.51/device2024-01: 0 reports for this device; peer average 6.95/device2024-02: 0 reports for this device; peer average 7.33/device2024-03: 0 reports for this device; peer average 7.06/device2024-04: 0 reports for this device; peer average 9.02/device2024-05: 0 reports for this device; peer average 9.82/device2024-06: 0 reports for this device; peer average 12.93/device2024-07: 0 reports for this device; peer average 11.19/device2024-08: 0 reports for this device; peer average 10.99/device2024-09: 0 reports for this device; peer average 11.47/device2024-10: 0 reports for this device; peer average 12.31/device2024-11: 0 reports for this device; peer average 7.7/device2024-12: 0 reports for this device; peer average 9.64/device2025-01: 0 reports for this device; peer average 9.94/device2025-02: 0 reports for this device; peer average 9.22/device2025-03: 0 reports for this device; peer average 9.64/device2025-04: 0 reports for this device; peer average 8.75/device2025-05: 0 reports for this device; peer average 8.5/device2025-06: 0 reports for this device; peer average 8.09/device2025-07: 0 reports for this device; peer average 8.43/device2025-08: 0 reports for this device; peer average 10.24/device2025-09: 0 reports for this device; peer average 7.63/device2025-10: 0 reports for this device; peer average 9.27/device2025-11: 0 reports for this device; peer average 10.27/device2025-12: 0 reports for this device; peer average 14.39/device2026-01: 0 reports for this device; peer average 9.3/device2026-02: 0 reports for this device; peer average 10.29/device2026-03: 0 reports for this device; peer average 13.53/device2026-04: 0 reports for this device; peer average 13.09/device2026-05: 0 reports for this device; peer average 12/device2026-06: 0 reports for this device; peer average 8.97/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.43
2019-0203.51
2019-0302.93
2019-0403.05
2019-0502.43
2019-0603.47
2019-0702.39
2019-0802.46
2019-0902.44
2019-1002.63
2019-1102.09
2019-1202.39
2020-0102.52
2020-0202.61
2020-0302.29
2020-0402.67
2020-0502.07
2020-0602.94
2020-0702.97
2020-0804.49
2020-0904.48
2020-1004.2
2020-1104.89
2020-1204.26
2021-0104.25
2021-0204.11
2021-0305.32
2021-0405.3
2021-0504.65
2021-0604.81
2021-0704.16
2021-0804.26
2021-0904.34
2021-1004.38
2021-1103.77
2021-1205.07
2022-0105.65
2022-0206.64
2022-0306.91
2022-0408.13
2022-0506.75
2022-0607.83
2022-0708.06
2022-0807.93
2022-0906.85
2022-1006.52
2022-1106.9
2022-1208.74
2023-0108.38
2023-0206.35
2023-0308.43
2023-0407.18
2023-0507.55
2023-0608.77
2023-0707.75
2023-0807.83
2023-0907.85
2023-1007.98
2023-1107.67
2023-1207.51
2024-0106.95
2024-0207.33
2024-0307.06
2024-0409.02
2024-0509.82
2024-06012.93
2024-07011.19
2024-08010.99
2024-09011.47
2024-10012.31
2024-1107.7
2024-1209.64
2025-0109.94
2025-0209.22
2025-0309.64
2025-0408.75
2025-0508.5
2025-0608.09
2025-0708.43
2025-08010.24
2025-0907.63
2025-1009.27
2025-11010.27
2025-12014.39
2026-0109.3
2026-02010.29
2026-03013.53
2026-04013.09
2026-05012
2026-0608.97
This device (reports/month)Average device in GCJ, HET, NMH (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K203255 — cites (transitively): K150377 (d1), K150633 (d1), K200216 (d1), K113203 (d2), K923982 (d2), K080560 (d2), K151011 (d2), K941541 (d2), K981751 (d2), K102379 (d3), K102059 (d3), K111425 (d3), K083155 (d4), K943304 (d4), K943307 (d4), K061313 (d4), K062049 (d4), K080948 (d4), K100584 (d4), K051645 (d5) — cited as predicate by K221252

K221252 — cites (transitively): K182606 (d1), K203255 (d1), K150956 (d2), K161792 (d2), K150377 (d2), K150633 (d2), K200216 (d2), K113203 (d3), K923982 (d3), K091515 (d3), K141077 (d3), K142310 (d3), K080560 (d3), K151011 (d3), K941541 (d3), K981751 (d3), K102379 (d4), K124031 (d4), K132785 (d4), K910132 (d4), K102059 (d4), K111425 (d4), K083155 (d5), K943304 (d5), K943307 (d5), K061313 (d5), K062049 (d5), K080948 (d5), K100584 (d5), K983566 (d5), K051645 (d6) — cited as predicate by K223557

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

Manufacturer compliance record — Scivita Medical Technology Co., Ltd.

  • VAI 2025-04-10 SCIVITA MEDICAL TECHNOLOGY CO LTD · 0 citations
  • VAI 2025-04-10 SCIVITA MEDICAL TECHNOLOGY CO LTD · 0 citations