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Flexible Video Cystoscope (NTSC)

Model CST-5000S · COGENTIX MEDICAL, INC. · DI 00874485002961

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

UDILibrary device dossier · generated 2026-09-06 · 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.

91827362019-02: 0 reports for this device; peer average 2/device2019-03: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 3/device2019-09: 0 reports for this device; peer average 4/device2019-10: 0 reports for this device; peer average 2/device2019-12: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 2.5/device2020-06: 0 reports for this device; peer average 1.33/device2020-07: 0 reports for this device; peer average 2.5/device2020-08: 0 reports for this device; peer average 1.33/device2020-09: 0 reports for this device; peer average 2.25/device2020-10: 0 reports for this device; peer average 2/device2020-11: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 5.67/device2021-01: 0 reports for this device; peer average 3.75/device2021-02: 0 reports for this device; peer average 10.43/device2021-03: 0 reports for this device; peer average 4/device2021-04: 0 reports for this device; peer average 2.33/device2021-05: 0 reports for this device; peer average 2.6/device2021-06: 0 reports for this device; peer average 3.8/device2021-07: 0 reports for this device; peer average 3.44/device2021-08: 0 reports for this device; peer average 3/device2021-09: 0 reports for this device; peer average 3.5/device2021-10: 0 reports for this device; peer average 3.5/device2021-11: 0 reports for this device; peer average 4/device2021-12: 0 reports for this device; peer average 4.5/device2022-01: 0 reports for this device; peer average 3.33/device2022-02: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 4/device2022-04: 0 reports for this device; peer average 3.33/device2022-05: 0 reports for this device; peer average 3/device2022-06: 0 reports for this device; peer average 3/device2022-07: 0 reports for this device; peer average 3.44/device2022-08: 0 reports for this device; peer average 2.5/device2022-09: 0 reports for this device; peer average 3.4/device2022-10: 0 reports for this device; peer average 4/device2022-11: 0 reports for this device; peer average 3.36/device2022-12: 0 reports for this device; peer average 2.9/device2023-01: 0 reports for this device; peer average 2.7/device2023-02: 0 reports for this device; peer average 2.77/device2023-03: 0 reports for this device; peer average 2.44/device2023-04: 0 reports for this device; peer average 4/device2023-05: 0 reports for this device; peer average 2.55/device2023-06: 0 reports for this device; peer average 3.42/device2023-07: 0 reports for this device; peer average 3.08/device2023-08: 0 reports for this device; peer average 2.67/device2023-09: 0 reports for this device; peer average 2.38/device2023-10: 0 reports for this device; peer average 3.75/device2023-11: 0 reports for this device; peer average 3.5/device2023-12: 0 reports for this device; peer average 7.82/device2024-01: 0 reports for this device; peer average 5.67/device2024-02: 0 reports for this device; peer average 7.1/device2024-03: 0 reports for this device; peer average 7.2/device2024-04: 0 reports for this device; peer average 3.4/device2024-05: 0 reports for this device; peer average 2.17/device2024-06: 0 reports for this device; peer average 3.42/device2024-07: 0 reports for this device; peer average 3.42/device2024-08: 0 reports for this device; peer average 4.42/device2024-09: 0 reports for this device; peer average 2.4/device2024-10: 0 reports for this device; peer average 3.67/device2024-11: 0 reports for this device; peer average 2.18/device2024-12: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1.82/device2025-02: 0 reports for this device; peer average 3.09/device2025-03: 0 reports for this device; peer average 2.38/device2025-04: 0 reports for this device; peer average 2.43/device2025-05: 0 reports for this device; peer average 3.36/device2025-06: 0 reports for this device; peer average 2.91/device2025-07: 0 reports for this device; peer average 4/device2025-08: 0 reports for this device; peer average 5.85/device2025-09: 0 reports for this device; peer average 6.22/device2025-10: 0 reports for this device; peer average 36.23/device2025-11: 0 reports for this device; peer average 13.06/device2025-12: 0 reports for this device; peer average 4.82/device2026-01: 0 reports for this device; peer average 10.87/device2026-02: 0 reports for this device; peer average 8.38/device2026-03: 0 reports for this device; peer average 5.27/device2026-04: 0 reports for this device; peer average 16.2/device2026-05: 0 reports for this device; peer average 11.9/device2026-06: 0 reports for this device; peer average 12.06/device02030508091012020406070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0202
2019-0301
2019-0502
2019-0803
2019-0904
2019-1002
2019-1201
2020-0201
2020-0402.5
2020-0601.33
2020-0702.5
2020-0801.33
2020-0902.25
2020-1002
2020-1102
2020-1205.67
2021-0103.75
2021-02010.43
2021-0304
2021-0402.33
2021-0502.6
2021-0603.8
2021-0703.44
2021-0803
2021-0903.5
2021-1003.5
2021-1104
2021-1204.5
2022-0103.33
2022-0203
2022-0304
2022-0403.33
2022-0503
2022-0603
2022-0703.44
2022-0802.5
2022-0903.4
2022-1004
2022-1103.36
2022-1202.9
2023-0102.7
2023-0202.77
2023-0302.44
2023-0404
2023-0502.55
2023-0603.42
2023-0703.08
2023-0802.67
2023-0902.38
2023-1003.75
2023-1103.5
2023-1207.82
2024-0105.67
2024-0207.1
2024-0307.2
2024-0403.4
2024-0502.17
2024-0603.42
2024-0703.42
2024-0804.42
2024-0902.4
2024-1003.67
2024-1102.18
2024-1201
2025-0101.82
2025-0203.09
2025-0302.38
2025-0402.43
2025-0503.36
2025-0602.91
2025-0704
2025-0805.85
2025-0906.22
2025-10036.23
2025-11013.06
2025-1204.82
2026-01010.87
2026-0208.38
2026-0305.27
2026-04016.2
2026-05011.9
2026-06012.06
This device (reports/month)Average device in FAJ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K072180 — cited as predicate by K160766, K181292, K181909, 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