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Hercules

Model G35267 · COOK INCORPORATED · DI 00827002352674

KCF — Dilator, Esophageal, Ent · Class I · 21 CFR 874.4420

UDILibrary device dossier · generated 2026-09-13 · 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.

01112021-03: 0 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 1/device0304
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-0301
2023-0401
This device (reports/month)Average device in KCF (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — COOK INCORPORATED

  • Warning Letter 2014-09-16 Cook Incorporated
  • Warning Letter 2014-09-16 Cook Incorporated
  • VAI 2025-06-04 Cook Incorporated · 6 citations
  • VAI 2025-06-04 Cook Incorporated · 6 citations
  • VAI 2024-05-08 Cook Incorporated · 1 citations
  • VAI 2024-05-08 Cook Incorporated · 1 citations
  • VAI 2021-09-14 Cook Incorporated · 2 citations
  • VAI 2021-09-14 Cook Incorporated · 2 citations
  • VAI 2020-02-07 Cook Incorporated · 4 citations
  • VAI 2020-02-07 Cook Incorporated · 4 citations
  • VAI 2018-06-14 Cook Incorporated · 1 citations
  • VAI 2018-06-14 Cook Incorporated · 1 citations
  • VAI 2017-05-26 Cook Incorporated · 3 citations
  • VAI 2017-05-26 Cook Incorporated · 3 citations
  • VAI 2017-01-26 Cook Incorporated · 11 citations
  • VAI 2017-01-26 Cook Incorporated · 11 citations
  • VAI 2016-06-17 Cook Inc · 2 citations
  • VAI 2016-06-17 Cook Inc · 2 citations
  • NAI 2016-03-31 Cook Inc · 0 citations
  • NAI 2016-03-31 Cook Inc · 0 citations
  • VAI 2015-03-13 Cook Incorporated · 5 citations
  • VAI 2015-03-13 Cook Incorporated · 5 citations