Integra®
Model OCS2PND · INTEGRA NEUROSCIENCES IMPLANT (FRANCE) · DI 10381780037217
GYC — Electrode, Cortical · Class II · 21 CFR 882.1310
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 (1)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2013-03-18 | Z-1030-2013 | Class II | Terminated | If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as static electricity) comes in contact with the outer case of the unit, that voltage could be transmitted to the patient and could be a potential source of injury. | k number procode |
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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2020-01 | 0 | 1 |
| 2022-10 | 0 | 3 |
| 2023-08 | 0 | 1 |
| 2024-05 | 0 | 3 |
| 2024-12 | 0 | 6 |
| 2025-09 | 0 | 3 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K924226 — cited as predicate by K110410, K112881, K151354
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
Nothing in the loaded window.