510(k) K163142 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader
| Applicant | ArthroCare Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Jan 6, 2017 |
| Received | Nov 9, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163142
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2020 | ArthroCare Corporation Speed Stitch Needle Cassette Open, Classified |
HXK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.