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EndoSheath Technology

Model BF-2.1 · COGENTIX MEDICAL, INC. · DI 00874485003029

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

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.

112234452019-01: 0 reports for this device; peer average 1.2/device2019-02: 0 reports for this device; peer average 1.5/device2019-03: 0 reports for this device; peer average 6.89/device2019-04: 0 reports for this device; peer average 44.75/device2019-05: 0 reports for this device; peer average 4/device2019-06: 0 reports for this device; peer average 3/device2019-07: 0 reports for this device; peer average 2.54/device2019-08: 0 reports for this device; peer average 4.78/device2019-09: 0 reports for this device; peer average 2.78/device2019-10: 0 reports for this device; peer average 2.57/device2019-11: 0 reports for this device; peer average 2.4/device2019-12: 0 reports for this device; peer average 4.25/device2020-01: 0 reports for this device; peer average 2.92/device2020-02: 0 reports for this device; peer average 6.2/device2020-03: 0 reports for this device; peer average 2.33/device2020-04: 0 reports for this device; peer average 4.31/device2020-05: 0 reports for this device; peer average 2.93/device2020-06: 0 reports for this device; peer average 4.24/device2020-07: 0 reports for this device; peer average 4.65/device2020-08: 0 reports for this device; peer average 4.5/device2020-09: 0 reports for this device; peer average 3.76/device2020-10: 0 reports for this device; peer average 3.91/device2020-11: 0 reports for this device; peer average 4.52/device2020-12: 0 reports for this device; peer average 6.57/device2021-01: 0 reports for this device; peer average 4.39/device2021-02: 0 reports for this device; peer average 4.04/device2021-03: 0 reports for this device; peer average 5.57/device2021-04: 0 reports for this device; peer average 4.75/device2021-05: 0 reports for this device; peer average 5.1/device2021-06: 0 reports for this device; peer average 4.02/device2021-07: 0 reports for this device; peer average 3.22/device2021-08: 0 reports for this device; peer average 4.9/device2021-09: 0 reports for this device; peer average 4.18/device2021-10: 0 reports for this device; peer average 4.75/device2021-11: 0 reports for this device; peer average 3.93/device2021-12: 0 reports for this device; peer average 4.87/device2022-01: 0 reports for this device; peer average 4.98/device2022-02: 0 reports for this device; peer average 4.54/device2022-03: 0 reports for this device; peer average 6.65/device2022-04: 0 reports for this device; peer average 6.56/device2022-05: 0 reports for this device; peer average 5.72/device2022-06: 0 reports for this device; peer average 6.05/device2022-07: 0 reports for this device; peer average 6.22/device2022-08: 0 reports for this device; peer average 5.78/device2022-09: 0 reports for this device; peer average 5.19/device2022-10: 0 reports for this device; peer average 5.56/device2022-11: 0 reports for this device; peer average 5.65/device2022-12: 0 reports for this device; peer average 5.77/device2023-01: 0 reports for this device; peer average 8/device2023-02: 0 reports for this device; peer average 5.67/device2023-03: 0 reports for this device; peer average 7.22/device2023-04: 0 reports for this device; peer average 5.99/device2023-05: 0 reports for this device; peer average 6.6/device2023-06: 0 reports for this device; peer average 6.31/device2023-07: 0 reports for this device; peer average 6.17/device2023-08: 0 reports for this device; peer average 7.54/device2023-09: 0 reports for this device; peer average 6.8/device2023-10: 0 reports for this device; peer average 6.71/device2023-11: 0 reports for this device; peer average 7.17/device2023-12: 0 reports for this device; peer average 7.04/device2024-01: 0 reports for this device; peer average 6.36/device2024-02: 0 reports for this device; peer average 6.05/device2024-03: 0 reports for this device; peer average 7.21/device2024-04: 0 reports for this device; peer average 6.19/device2024-05: 0 reports for this device; peer average 6.2/device2024-06: 0 reports for this device; peer average 7.13/device2024-07: 0 reports for this device; peer average 6.06/device2024-08: 0 reports for this device; peer average 7.7/device2024-09: 0 reports for this device; peer average 6.97/device2024-10: 0 reports for this device; peer average 8.15/device2024-11: 0 reports for this device; peer average 10.86/device2024-12: 0 reports for this device; peer average 4.17/device2025-01: 0 reports for this device; peer average 4.16/device2025-02: 0 reports for this device; peer average 3.73/device2025-03: 0 reports for this device; peer average 4.21/device2025-04: 0 reports for this device; peer average 4.31/device2025-05: 0 reports for this device; peer average 4.93/device2025-06: 0 reports for this device; peer average 4.86/device2025-07: 0 reports for this device; peer average 5.79/device2025-08: 0 reports for this device; peer average 5.13/device2025-09: 0 reports for this device; peer average 4.38/device2025-10: 0 reports for this device; peer average 5.19/device2025-11: 0 reports for this device; peer average 6.62/device2025-12: 0 reports for this device; peer average 10.31/device2026-01: 0 reports for this device; peer average 8.47/device2026-02: 0 reports for this device; peer average 6.48/device2026-03: 0 reports for this device; peer average 6.61/device2026-04: 0 reports for this device; peer average 8.85/device2026-05: 0 reports for this device; peer average 9.34/device2026-06: 0 reports for this device; peer average 8.3/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.2
2019-0201.5
2019-0306.89
2019-04044.75
2019-0504
2019-0603
2019-0702.54
2019-0804.78
2019-0902.78
2019-1002.57
2019-1102.4
2019-1204.25
2020-0102.92
2020-0206.2
2020-0302.33
2020-0404.31
2020-0502.93
2020-0604.24
2020-0704.65
2020-0804.5
2020-0903.76
2020-1003.91
2020-1104.52
2020-1206.57
2021-0104.39
2021-0204.04
2021-0305.57
2021-0404.75
2021-0505.1
2021-0604.02
2021-0703.22
2021-0804.9
2021-0904.18
2021-1004.75
2021-1103.93
2021-1204.87
2022-0104.98
2022-0204.54
2022-0306.65
2022-0406.56
2022-0505.72
2022-0606.05
2022-0706.22
2022-0805.78
2022-0905.19
2022-1005.56
2022-1105.65
2022-1205.77
2023-0108
2023-0205.67
2023-0307.22
2023-0405.99
2023-0506.6
2023-0606.31
2023-0706.17
2023-0807.54
2023-0906.8
2023-1006.71
2023-1107.17
2023-1207.04
2024-0106.36
2024-0206.05
2024-0307.21
2024-0406.19
2024-0506.2
2024-0607.13
2024-0706.06
2024-0807.7
2024-0906.97
2024-1008.15
2024-11010.86
2024-1204.17
2025-0104.16
2025-0203.73
2025-0304.21
2025-0404.31
2025-0504.93
2025-0604.86
2025-0705.79
2025-0805.13
2025-0904.38
2025-1005.19
2025-1106.62
2025-12010.31
2026-0108.47
2026-0206.48
2026-0306.61
2026-0408.85
2026-0509.34
2026-0608.3
This device (reports/month)Average device in EOQ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K091768 — cited as predicate by K130845, K173727, K181292

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