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
10
510(K)/PMA CLEARANCES
510k: 10
0
RECALL ENTRIES
Recent clearances
K253761Devicor Medical Products, Inc. · 510k2026-01-23
K253888Stryker Endoscopy · 510k2025-12-31
K252892Merit Medical Systems, Inc. · 510k2025-12-19
K251989Breast-Med, Inc. · 510k2025-12-12
K251748Carbon Medical Technologies, Inc. · 510k2025-07-23
K243642Bard Peripheral Vascular, Inc. · 510k2025-03-24
K233639Elucent Medical, Inc. · 510k2024-12-20
K240429Inrad, Inc. · 510k2024-11-07
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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