510(k) K123268 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
SMARTSTITCH PERFECTPASSER SYSTEM
| Applicant | Arthocare Corporation, Austin TX, US |
| Decision | Substantially Equivalent, Nov 7, 2012 |
| Received | Oct 19, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123268
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 21, 2019 | ArthroCare Corporation Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971 Terminated |
GAT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.