510(k) K160564 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
TroClose1200
| Applicant | Gordian Surgical, Ltd., Karmiel, IL |
| Decision | Substantially Equivalent, Nov 17, 2016 |
| Received | Feb 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160564
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2020 | Gordian Surgical TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and urologic endoscopic procedures, to create and maintain a port of entry and to facilitate the delivery of absorb Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.