DEVICE CLASS
Class II
REGULATION
21 CFR 882.4725
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
6
510(K)/PMA CLEARANCES
510k: 6
0
RECALL ENTRIES
Recent clearances
K253907ABBOTT MEDICAL · 510k2026-04-16
K251802Merit Medical Systems, Inc. · 510k2026-02-13
K251243Neuroone Medical Technologies Corp. · 510k2025-08-15
K242841ABBOTT MEDICAL · 510k2025-05-27
K250213Stryker Instruments · 510k2025-05-15
K241367Shanghai Samedical & Plastic Instruments Co., Ltd. · 510k2025-01-23
Related on SPEQ
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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