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UNITY 9000

Model UVP-9000 · COGENTIX MEDICAL, INC. · DI 00874485003227

EOB — Nasopharyngoscope (Flexible Or Rigid) · Class II · 21 CFR 874.4760

EOQ — Bronchoscope (Flexible Or Rigid) · Class II · 21 CFR 874.4680

EOX — Esophagoscope (Flexible Or Rigid) · Class II · 21 CFR 874.4710

FAJ — Cystoscope And Accessories, Flexible/Rigid · Class II · 21 CFR 876.1500

OCS — Endoscopic Video Imaging System/Component, Gastroenterology-Urology · Class II · 21 CFR 876.1500

UDILibrary device dossier · generated 2026-09-07 · 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.

122437492019-01: 0 reports for this device; peer average 1.81/device2019-02: 0 reports for this device; peer average 2/device2019-03: 0 reports for this device; peer average 8.79/device2019-04: 0 reports for this device; peer average 48.8/device2019-05: 0 reports for this device; peer average 4.95/device2019-06: 0 reports for this device; peer average 3.63/device2019-07: 0 reports for this device; peer average 2.96/device2019-08: 0 reports for this device; peer average 5.13/device2019-09: 0 reports for this device; peer average 3.87/device2019-10: 0 reports for this device; peer average 4.27/device2019-11: 0 reports for this device; peer average 4.13/device2019-12: 0 reports for this device; peer average 4.59/device2020-01: 0 reports for this device; peer average 4/device2020-02: 0 reports for this device; peer average 7.31/device2020-03: 0 reports for this device; peer average 3.47/device2020-04: 0 reports for this device; peer average 4.58/device2020-05: 0 reports for this device; peer average 3.28/device2020-06: 0 reports for this device; peer average 4.43/device2020-07: 0 reports for this device; peer average 4.69/device2020-08: 0 reports for this device; peer average 4.7/device2020-09: 0 reports for this device; peer average 4.29/device2020-10: 0 reports for this device; peer average 5.28/device2020-11: 0 reports for this device; peer average 5.1/device2020-12: 0 reports for this device; peer average 7.83/device2021-01: 0 reports for this device; peer average 4.75/device2021-02: 0 reports for this device; peer average 5.58/device2021-03: 0 reports for this device; peer average 6.95/device2021-04: 0 reports for this device; peer average 4.86/device2021-05: 0 reports for this device; peer average 5.77/device2021-06: 0 reports for this device; peer average 4.59/device2021-07: 0 reports for this device; peer average 3.71/device2021-08: 0 reports for this device; peer average 5.21/device2021-09: 0 reports for this device; peer average 4.74/device2021-10: 0 reports for this device; peer average 5.47/device2021-11: 0 reports for this device; peer average 4.45/device2021-12: 0 reports for this device; peer average 5.27/device2022-01: 0 reports for this device; peer average 5.72/device2022-02: 0 reports for this device; peer average 5.11/device2022-03: 0 reports for this device; peer average 7.13/device2022-04: 0 reports for this device; peer average 7.17/device2022-05: 0 reports for this device; peer average 5.91/device2022-06: 0 reports for this device; peer average 6.96/device2022-07: 0 reports for this device; peer average 6.9/device2022-08: 0 reports for this device; peer average 6.37/device2022-09: 0 reports for this device; peer average 6.1/device2022-10: 0 reports for this device; peer average 6.15/device2022-11: 0 reports for this device; peer average 5.97/device2022-12: 0 reports for this device; peer average 6.02/device2023-01: 0 reports for this device; peer average 7.24/device2023-02: 0 reports for this device; peer average 5.69/device2023-03: 0 reports for this device; peer average 7.31/device2023-04: 0 reports for this device; peer average 6.52/device2023-05: 0 reports for this device; peer average 6.1/device2023-06: 0 reports for this device; peer average 6.17/device2023-07: 0 reports for this device; peer average 6.09/device2023-08: 0 reports for this device; peer average 7.92/device2023-09: 0 reports for this device; peer average 7.15/device2023-10: 0 reports for this device; peer average 7.2/device2023-11: 0 reports for this device; peer average 8.1/device2023-12: 0 reports for this device; peer average 7.61/device2024-01: 0 reports for this device; peer average 6.33/device2024-02: 0 reports for this device; peer average 7.65/device2024-03: 0 reports for this device; peer average 7.65/device2024-04: 0 reports for this device; peer average 6.91/device2024-05: 0 reports for this device; peer average 6.38/device2024-06: 0 reports for this device; peer average 7.45/device2024-07: 0 reports for this device; peer average 6.92/device2024-08: 0 reports for this device; peer average 8.03/device2024-09: 0 reports for this device; peer average 7.19/device2024-10: 0 reports for this device; peer average 7.97/device2024-11: 0 reports for this device; peer average 9.19/device2024-12: 0 reports for this device; peer average 4.19/device2025-01: 0 reports for this device; peer average 3.89/device2025-02: 0 reports for this device; peer average 3.58/device2025-03: 0 reports for this device; peer average 4.04/device2025-04: 0 reports for this device; peer average 4.66/device2025-05: 0 reports for this device; peer average 4.46/device2025-06: 0 reports for this device; peer average 4.75/device2025-07: 0 reports for this device; peer average 5.75/device2025-08: 0 reports for this device; peer average 4.8/device2025-09: 0 reports for this device; peer average 4.29/device2025-10: 0 reports for this device; peer average 8.2/device2025-11: 0 reports for this device; peer average 6.97/device2025-12: 0 reports for this device; peer average 7.11/device2026-01: 0 reports for this device; peer average 7.08/device2026-02: 0 reports for this device; peer average 6.25/device2026-03: 0 reports for this device; peer average 5.51/device2026-04: 0 reports for this device; peer average 8.85/device2026-05: 0 reports for this device; peer average 8.57/device2026-06: 0 reports for this device; peer average 7.55/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.81
2019-0202
2019-0308.79
2019-04048.8
2019-0504.95
2019-0603.63
2019-0702.96
2019-0805.13
2019-0903.87
2019-1004.27
2019-1104.13
2019-1204.59
2020-0104
2020-0207.31
2020-0303.47
2020-0404.58
2020-0503.28
2020-0604.43
2020-0704.69
2020-0804.7
2020-0904.29
2020-1005.28
2020-1105.1
2020-1207.83
2021-0104.75
2021-0205.58
2021-0306.95
2021-0404.86
2021-0505.77
2021-0604.59
2021-0703.71
2021-0805.21
2021-0904.74
2021-1005.47
2021-1104.45
2021-1205.27
2022-0105.72
2022-0205.11
2022-0307.13
2022-0407.17
2022-0505.91
2022-0606.96
2022-0706.9
2022-0806.37
2022-0906.1
2022-1006.15
2022-1105.97
2022-1206.02
2023-0107.24
2023-0205.69
2023-0307.31
2023-0406.52
2023-0506.1
2023-0606.17
2023-0706.09
2023-0807.92
2023-0907.15
2023-1007.2
2023-1108.1
2023-1207.61
2024-0106.33
2024-0207.65
2024-0307.65
2024-0406.91
2024-0506.38
2024-0607.45
2024-0706.92
2024-0808.03
2024-0907.19
2024-1007.97
2024-1109.19
2024-1204.19
2025-0103.89
2025-0203.58
2025-0304.04
2025-0404.66
2025-0504.46
2025-0604.75
2025-0705.75
2025-0804.8
2025-0904.29
2025-1008.2
2025-1106.97
2025-1207.11
2026-0107.08
2026-0206.25
2026-0305.51
2026-0408.85
2026-0508.57
2026-0607.55
This device (reports/month)Average device in EOB, EOQ, EOX, FAJ, OCS (reports/device/month)

Regulatory clearances

  • K181292 SESE 2018-11-15 (k number procode)

Predicate lineage

K181292 — cites (transitively): K072088 (d1), K072180 (d1), K091768 (d1), K102733 (d1), K182129 (d1), K043395 (d2), K072073 (d2), K072879 (d2), K081051 (d2), K153343 (d2), K170396 (d2), K173600 (d2), K133435 (d3), K141977 (d3), K151579 (d3), K151597 (d3), K121434 (d3), K123510 (d3), K150843 (d3), K162102 (d3), K163312 (d3), K152283 (d3), K082427 (d4), K091114 (d4), K103274 (d4), K073194 (d4), K090038 (d4), K121160 (d4), K121459 (d4), K132831 (d4), K132951 (d4), K140253 (d4), K140998 (d4), K130885 (d4), K132119 (d4), K050263 (d4), K143311 (d4), K130262 (d4), K053042 (d5), K072237 (d5), K092519 (d5), K060873 (d5), K071925 (d5), K083166 (d5), K100141 (d5), K101347 (d5), K123938 (d5), K041112 (d6) — cited as predicate by K253905

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

Manufacturer compliance record — COGENTIX MEDICAL, INC.

  • VAI 2022-04-14 Cogentix Medical, Inc. · 1 citations
  • VAI 2022-04-14 Cogentix Medical, Inc. · 1 citations
  • NAI 2020-02-28 Cogentix Medical LLC · 0 citations
  • NAI 2020-02-28 Cogentix Medical LLC · 0 citations
  • NAI 2017-08-31 Cogentix Medical LLC · 0 citations
  • NAI 2017-08-31 Cogentix Medical LLC · 0 citations
  • VAI 2014-08-08 Cogentix Medical, Inc. · 2 citations
  • VAI 2014-08-08 Cogentix Medical, Inc. · 2 citations
  • VAI 2013-05-01 Cogentix Medical, Inc. · 2 citations
  • VAI 2013-05-01 Cogentix Medical, Inc. · 2 citations
  • NAI 2012-06-01 Cogentix Medical LLC · 0 citations
  • NAI 2012-06-01 Cogentix Medical LLC · 0 citations
  • VAI 2011-02-11 Cogentix Medical, Inc. · 4 citations
  • VAI 2011-02-11 Cogentix Medical, Inc. · 4 citations