Panels › Gastroenterology, Urology › Product code GCI · Class 2
Laryngoscope, Endoscope
Regulation 876.1500
0510(k)s in 12 months (14 all time)
0recalls in 12 months (5 all time)
4recalls that name a 510(k)
Top companies in GCI
| Company | 510(k)s | Recalls |
|---|---|---|
| Covidien Llc | 0 | 4 |
| Birtcher Medical Systems, Inc. | 2 | 0 |
| Conmedcorp | 2 | 0 |
| Computer Motion, Inc. | 1 | 0 |
| Dexide, Inc. | 1 | 0 |
| Ellman Intl. Mfg., Inc. | 1 | 0 |
| ETHICON, Inc. | 1 | 0 |
| EXP Pharmaceutical Services Corp | 0 | 1 |
| Karl Storz Imaging, Inc. | 1 | 0 |
| Northgate Technologies, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K912097 |
| 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 | K912097 |
| 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 | K912097 |
| 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 | K912097 |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange - Endo Catch 10mm;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number 173050G;
EXP (repackager), Auto Suture (OEM)
Endoscope and Accessories Terminated |
GCI | None listed |
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