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Flexible Video Esophagoscope (NTSC)

Model TNE-5000 · COGENTIX MEDICAL, INC. · DI 00874485000844

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

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.

24572020-10: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 3/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 7/device101201040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-1001
2022-1201
2023-0103
2023-0401
2023-0501
2023-0607
This device (reports/month)Average device in EOX (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

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