FDA Product Code
FDA Product Code GCI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 14 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K021747 | DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR | Surgicon, Inc. | 2002-08-15 | Traditional | PDF ↗ |
| K003222 | MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER | Computer Motion, Inc. | 2000-11-03 | Special | PDF ↗ |
| K001362 | KARL STORZ 3D VIDEO SYSTEM | Karl Storz Imaging, Inc. | 2000-07-17 | Traditional | PDF ↗ |
| K930302 | BIRTCHER SURE CLEAN INSTRUMENT SYSTEM | Birtcher Medical Systems, Inc. | 1993-10-27 | Traditional | PDF ↗ |
| K933515 | BOOTY ENDOSCOPE WARMER | T-Med, Inc. | 1993-10-27 | Traditional | PDF ↗ |
| K930496 | GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS | Birtcher Medical Systems, Inc. | 1993-04-20 | Traditional | PDF ↗ |
| K922123 | AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH | United States Surgical, A Division of Tyco Healthc | 1993-02-01 | Traditional | PDF ↗ |
| K920139 | GLEESON CLOT-BUSTER | Conmedcorp | 1992-04-15 | Traditional | PDF ↗ |
| K915762 | POOLE TIP SUCTION PROBE | O.R. Concepts, Inc. | 1992-03-13 | Traditional | PDF ↗ |
| K914120 | SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT | Conmedcorp | 1991-10-30 | Traditional | PDF ↗ |
| K911829 | ENDOSTAPLE | ETHICON, Inc. | 1991-08-28 | Traditional | PDF ↗ |
| K911461 | SURGITRON | Ellman Intl. Mfg., Inc. | 1991-04-25 | Traditional | PDF ↗ |
| K905117 | ENDOSCOPE AND ACCESSORIES | Northgate Technologies, Inc. | 1991-04-25 | Traditional | PDF ↗ |
| K896205 | MONOSCOPY BRAND, 5 MM LOCKING TROCAR SLEEVE | Dexide, Inc. | 1990-03-22 | Traditional | PDF ↗ |
Product code GCI · Class II · Gastroenterology, Urology. Data: openFDA.