DEVICE CLASS
Class II
REGULATION
21 CFR 882.4560
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
13
510(K)/PMA CLEARANCES
510k: 13
0
RECALL ENTRIES
Recent clearances
K253663Zeta Surgical, Inc. · 510k2026-05-01
K253379Medtronic Navigation, Inc. · 510k2026-03-26
K231897Medivis, Inc. · 510k2025-10-21
K251317Intravent Medical Partners · 510k2025-09-05
K250893Bayer Medical Care, Inc. · 510k2025-09-04
K250505Phasor Health, LLC · 510k2025-07-09
K242575Brain Navi Biotechnology Co., Ltd. · 510k2025-05-23
K241327Claronav · 510k2025-02-05
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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