510(k) K111442 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)...
| Applicant | Covidien, Formerly US Surgical A Divison of Tyco H, North Haven CT, US |
| Decision | Substantially Equivalent, Jun 3, 2011 |
| Received | May 24, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111442
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2022 | Covidien, LP Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L. Automated suturing device. Open, Classified |
GAM | None listed |
| Nov 11, 2022 | Covidien, LP Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L Open, Classified |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.