K253852 is an FDA 510(k) clearance for the MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture. This device is classified as a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II - Special Controls, product code GAM).
Submitted by Ethicon, Inc. (Raritan, US). The FDA issued a Cleared decision on February 6, 2026, 66 days after receiving the submission on December 2, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4493.
| 510(k) Number | K253852 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2025 |
| Decision Date | February 06, 2026 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4493 |