← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

GWF — Stimulator, Electrical, Evoked Response

DEVICE CLASS
Class II
REGULATION
21 CFR 882.1870
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES

Recent clearances

K253301Time IS Brain, S.L. · 510k2026-06-27
K252842Alphatec Spine, Inc. · 510k2026-01-11
K243982Natus Neurology Incorporated · 510k2025-01-22
K243495Natus Neurology Incorporated · 510k2024-12-12
K242345Quantalx Neuroscience · 510k2024-11-05

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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