510(k) K253852
MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture by
Ethicon, Inc.
— Product Code GAM
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 2026
- Date Received
- December 2, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Device Class
- Class II
- Regulation Number
- 878.4493
- Review Panel
- SU
- Submission Type