DEVICE CLASS
Class II
REGULATION
21 CFR 878.3300
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
K253956Sofradim Production · 510k2026-05-21
K253125Medtronic - Sofradim Production · 510k2025-10-24
K251955Davol Inc., Subsidiary of C. R. Bard, Inc. · 510k2025-07-24
K251557Davol, Inc. · 510k2025-06-12
K250869Sofradim Production · 510k2025-04-23
K250098Davol, Inc. · 510k2025-04-09
K243315Sofradim Production · 510k2025-01-17
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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