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ATLAS Headbox Interface Cable - Touchproof

Model Touchproof · NEURALYNX, INC. · DI 00850011306901

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

  • K250094 SESE 2025-04-14 (k number procode)

Predicate lineage

K250094 — cites (transitively): K110967 (d1), K180761 (d1), K183123 (d1), K053363 (d2), K060523 (d2), K082474 (d2), K071782 (d2), K122196 (d2), K151354 (d2), K171384 (d2), K181077 (d2), K071364 (d2), K000963 (d3), K090957 (d3), K072964 (d3), K082629 (d3), K110410 (d3), K924226 (d3), K080545 (d3)

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

Manufacturer compliance record — NEURALYNX, INC.

Nothing in the loaded window.