DEVICE CLASS
Class II
REGULATION
21 CFR 882.5950
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
8
510(K)/PMA CLEARANCES
510k: 8
0
RECALL ENTRIES
Recent clearances
K261772Stryker Neurovscular · 510k2026-06-24
K260351MicroPort NeuroTech (Shanghai) Co., Ltd. · 510k2026-05-20
K254221Balt USA, LLC · 510k2026-01-27
K252694Stryker Neurovascular · 510k2025-12-11
K251832Stryker Neurovascular · 510k2025-10-17
K252700Balt USA, LLC · 510k2025-09-26
K242154MicroPort NeuroTech (Shanghai) Co., Ltd. · 510k2024-09-30
K242582Balt USA, LLC · 510k2024-09-27
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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