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CORTAC

Model 2110-10-119 · PMT CORPORATION · DI 00650551001355

GYC — Electrode, Cortical · Class II · 21 CFR 882.1310

UDILibrary device dossier · generated 2026-09-11 · 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.

23562020-01: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 3/device2023-08: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 3/device2024-12: 0 reports for this device; peer average 6/device2025-09: 0 reports for this device; peer average 3/device011008051209
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0101
2022-1003
2023-0801
2024-0503
2024-1206
2025-0903
This device (reports/month)Average device in GYC (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K082474 — cited as predicate by K110967, K180290, K192764

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

Manufacturer compliance record — PMT CORPORATION

  • Warning Letter 2009-12-03 PMT Corporation
  • Warning Letter 2009-12-03 PMT Corporation
  • VAI 2024-02-15 PMT Corporation · 4 citations
  • VAI 2024-02-15 PMT Corporation · 4 citations
  • NAI 2017-03-23 PMT Corporation · 2 citations
  • NAI 2017-03-23 PMT Corporation · 2 citations
  • NAI 2013-06-06 PMT Corporation · 7 citations
  • NAI 2013-06-06 PMT Corporation · 7 citations
  • VAI 2010-07-16 PMT Corporation · 0 citations
  • VAI 2010-07-16 PMT Corporation · 0 citations