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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 15, 2002 | K021747 | DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR Surgicon, Inc. | GCI |
| Nov 3, 2000 | K003222 | MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER Computer Motion, Inc. | GCI |
| Jul 17, 2000 | K001362 | KARL STORZ 3D VIDEO SYSTEM Karl Storz Imaging, Inc. | GCI |
| Oct 27, 1993 | K933515 | BOOTY ENDOSCOPE WARMER T-Med, Inc. | GCI |
| Oct 27, 1993 | K930302 | BIRTCHER SURE CLEAN INSTRUMENT SYSTEM Birtcher Medical Systems, Inc. | GCI |
| Apr 20, 1993 | K930496 | GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS Birtcher Medical Systems, Inc. | GCI |
| Feb 1, 1993 | K922123 | AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH United States Surgical, A Division of Tyco Healthc | GCI |
| Apr 15, 1992 | K920139 | GLEESON CLOT-BUSTER Conmedcorp | GCI |
| Mar 13, 1992 | K915762 | POOLE TIP SUCTION PROBE O.R. Concepts, Inc. | GCI |
| Oct 30, 1991 | K914120 | SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT Conmedcorp | GCI |
| Aug 28, 1991 | K911829 | ENDOSTAPLE ETHICON, Inc. | GCI |
| Apr 25, 1991 | K911461 | SURGITRON Ellman Intl. Mfg., Inc. | GCI |
| Apr 25, 1991 | K905117 | ENDOSCOPE AND ACCESSORIES Northgate Technologies, Inc. | GCI |
| Mar 22, 1990 | K896205 | MONOSCOPY BRAND, 5 MM LOCKING TROCAR SLEEVE Dexide, Inc. | GCI |
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