510(k) K912097 ยท GCJ Laparoscope, General & Plastic Surgery
AUTO SUTURE ENDOSCOPIC FASCIA STAPLER
| Applicant | United States Surgical, A Division of Tyco Healthc, Norwalk CT, US |
| Decision | Substantially Equivalent, Sep 19, 1991 |
| Received | May 13, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912097
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2020 | Covidien Llc Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects Open, Classified |
GCI | None listed |
| May 12, 2020 | Covidien Llc Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects Open, Classified |
GCI | None listed |
| May 12, 2020 | Covidien Llc Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair o Open, Classified |
GCI | None listed |
| May 12, 2020 | Covidien Llc Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair o Open, Classified |
GCI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.