DEVICE CLASS
Class II
REGULATION
21 CFR 878.4750
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
7
510(K)/PMA CLEARANCES
510k: 7
0
RECALL ENTRIES
Recent clearances
K260196Ethicon Endo-Surgery, LLC · 510k2026-05-11
K253657Covidien (Part of Medtronic) · 510k2026-04-10
K252739Ethicon Endo-Surgery, LLC · 510k2025-12-17
K250835Ethicon Endo-Surgery, LLC · 510k2025-05-14
K243276Ethicon Endo-Surgery, LLC · 510k2025-02-25
K241630Ethicon Endo-Surgery, LLC · 510k2024-10-28
K242679Fengh Medical Co., Ltd. · 510k2024-10-04
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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