510(k) K934738 ยท OCW Endoscopic Tissue Approximation Device
AUTOSUTURE ENDOSCOPIC SUTURING DEVICE
| Applicant | United States Surgical, A Division of Tyco Healthc, Norwalk CT, US |
| Decision | Substantially Equivalent, Mar 16, 1994 |
| Received | Oct 1, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934738
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2026 | Covidien, LP Covidien EndoStitch" Polysorb Single Use Loading Unit;
Product numbers: 170053 and 170071; Open, Classified |
OCW | None listed |
| May 3, 2017 | Medtronic Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO STITCH POLYSORB 2/0 48" U/D DLU SU, Item Number:
1 Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.