510(k) K090470 ยท OCW Endoscopic Tissue Approximation Device
AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES
| Applicant | Covidien, North Haven CT, US |
| Decision | Substantially Equivalent, May 14, 2009 |
| Received | Feb 23, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090470
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2024 | Covidien LP AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm-
-intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures
Mo Open, Classified |
OCW | None listed |
| Mar 16, 2010 | Covidien LP Auto Suture ProTack Fixation 5 mm
Product Catalogue # 174006.
Has application in endoscopic surgery procedures. Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.