DEVICE CLASS
Class II
REGULATION
21 CFR 878.4350
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
22
510(K)/PMA CLEARANCES
510k: 22
0
RECALL ENTRIES
Recent clearances
K261068Serpex Medical · 510k2026-06-30
K261806Erbe Elektromedizin GmbH · 510k2026-06-09
K253230Erbe Elektromedizin GmbH · 510k2026-04-22
K252198Medical Brands Laboratories B.V. · 510k2026-04-02
K260377IceCure Medical , Ltd. · 510k2026-02-24
K251928Medinice S.A. · 510k2026-02-13
K251524Theotclab Healthcare B.V. · 510k2026-01-12
K250742Focused Cryo, Inc. · 510k2025-12-09
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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