← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
NEW — Suture, Surgical, Absorbable, Polydioxanone
DEVICE CLASS
Class II
REGULATION
21 CFR 878.4840
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
K261988Teleflex Medical, LLC · 510k2026-07-09
K252171Sutura Medical Technology, Inc. · 510k2026-06-12
K252047ETHICON, Inc. · 510k2026-05-18
K243897ETHICON, Inc. · 510k2025-11-12
K251414Feeltech Co., Ltd. · 510k2025-10-20
K250107Feeltech Co., Ltd. · 510k2025-10-15
K252644M/s. Meril Endo Surgery Private Limited. · 510k2025-09-23
K250977Suturion AB · 510k2025-04-28
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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