510(k) K183183 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Jun 27, 2019 |
| Received | Nov 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183183
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2025 | Ethicon Endo Surgery, LLC PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP Open, Classified |
NEW | None listed |
| Nov 7, 2024 | Ethicon, Inc. Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H Open, Classified |
GAM | None listed |
| Jun 14, 2024 | Ethicon, Inc. PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are p Open, Classified |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.