510(k) K960653 ยท GAN Suture, Absorbable, Synthetic
MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Mar 28, 1996 |
| Received | Feb 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960653
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 14, 2024 | Ethicon, Inc. MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated
PRODUCT CODE:
Y315H
Y345H
Y359H
Y398 Open, Classified |
GAN | None listed |
| May 12, 2009 | Ethicon, Inc. MONOCRYL (poliglecaprone 25 ) Suture,
Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ
Sutures are intended for general soft tissue approximation and/or ligation. Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.