510(k) K201996 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Monocryl Plus Antibacterial Suture
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Dec 21, 2020 |
| Received | Jul 20, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201996
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 14, 2024 | Ethicon, Inc. MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated.
PRODUCT CODE:
MCP266H13
MCP3 Open, Classified |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.