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Auragen™

Model 40M77 · INTEGRA NEUROSCIENCES IMPLANT (FRANCE) · DI 10381780035237

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

K082250 — cited as predicate by K102802

K926424 — cited as predicate by K102802

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

Manufacturer compliance record — INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Nothing in the loaded window.