DEVICE CLASS
Class II
REGULATION
21 CFR 878.4300
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES
Recent clearances
K253781Taiwan Surgical Corporation · 510k2025-12-22
K253903Taiwan Surgical Corporation · 510k2025-12-22
K250643Hangzhou Kangji Medical Instrument Co., Ltd. · 510k2025-11-20
K251054Teleflex Medical · 510k2025-07-03
K242541Synovis Micro Companies Alliance A Subsidiary of Baxter Int · 510k2025-01-15
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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