K253852
- 510(k) number
- K253852
- Device name
- MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
- Applicant
- ETHICON, Inc. NJ · US
- Product code
- GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid
- Decision date
- 2026-02-06
- Date received
- 2025-12-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K253852.pdf
Official FDA record: K253852
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.