ETHICON, Inc. · Class II · Cleared Feb 6, 2026
| K-number | K253852 |
| Device name | MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture |
| Applicant | ETHICON, Inc. |
| Product code | GAM |
| Device class | Class II |
| Decision date | Feb 6, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 878.4493 |
MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 is a sterile synthetic absorbable monofilament surgical suture composed of a copolymer of glycolide and epsilon-caprolactone, containing Triclosan as a broad-spectrum antibacterial agent. It is indicated for general soft tissue approximation and/or ligation, but not for use in cardiovascular, neurological, microsurgery, or ophthalmic applications.
The subject device shares the same fundamental scientific technology, design, materials, sterilization process (Ethylene Oxide), and sterility assurance level (SAL 10-6) as the predicate device. The primary difference is the device packaging—the subject device is available in plastic trays containing a means for Triclosan deposition, with Triclosan concentrations ranging from 77–2360 μg per meter of suture.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov