Product code GCI
- Device name
- Laryngoscope, Endoscope
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K021747 | DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR | Surgicon, Inc. | 2002-08-15 |
| K003222 | MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER | Computer Motion, Inc. | 2000-11-03 |
| K001362 | KARL STORZ 3D VIDEO SYSTEM | Karl Storz Imaging, Inc. | 2000-07-17 |
| K930302 | BIRTCHER SURE CLEAN INSTRUMENT SYSTEM | Birtcher Medical Systems, Inc. | 1993-10-27 |
| K933515 | BOOTY ENDOSCOPE WARMER | T-Med, Inc. | 1993-10-27 |
| K930496 | GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS | Birtcher Medical Systems, Inc. | 1993-04-20 |
| K922123 | AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH | United States Surgical, A Division of Tyco Healthc | 1993-02-01 |
| K920139 | GLEESON CLOT-BUSTER | Conmedcorp | 1992-04-15 |
| K915762 | POOLE TIP SUCTION PROBE | O.R. Concepts, Inc. | 1992-03-13 |
| K914120 | SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT | Conmedcorp | 1991-10-30 |
| K911829 | ENDOSTAPLE | ETHICON, Inc. | 1991-08-28 |
| K905117 | ENDOSCOPE AND ACCESSORIES | Northgate Technologies, Inc. | 1991-04-25 |
| K911461 | SURGITRON | Ellman Intl. Mfg., Inc. | 1991-04-25 |
| K896205 | MONOSCOPY BRAND, 5 MM LOCKING TROCAR SLEEVE | Dexide, Inc. | 1990-03-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B225100000230 | Orthoscan TAU MVP 2020 | Ziehm-Orthoscan, Inc. | 2026-04-30 |
| G4533352505380 | PEAK MEDICAL | Peak Medical Distribution Inc. | 2024-10-09 |
| 10850048763255 | Klein Surgical | Klein Surgical Systems, Inc. | 2023-07-17 |
| 10850048763651 | Klein Surgical | Klein Surgical Systems, Inc. | 2023-07-17 |
| 10850048763637 | Klein Surgical | Klein Surgical Systems, Inc. | 2023-07-17 |
| 10850048763620 | Klein Surgical | Klein Surgical Systems, Inc. | 2023-07-17 |
| 10850048763613 | Klein Surgical | Klein Surgical Systems, Inc. | 2023-07-17 |
| 10850048763354 | Klein Surgical | Klein Surgical Systems, Inc. | 2023-07-17 |
| 10850048763309 | Klein Surgical | Klein Surgical Systems, Inc. | 2023-07-17 |
| 10850048763286 | Klein Surgical | Klein Surgical Systems, Inc. | 2023-07-17 |
| 10850048763279 | Klein Surgical | Klein Surgical Systems, Inc. | 2023-07-17 |
| 10850048763262 | Klein Surgical | Klein Surgical Systems, Inc. | 2023-07-17 |
| 10850048763248 | Klein Surgical | Klein Surgical Systems, Inc. | 2023-07-17 |
| 10850048763231 | Klein Surgical | Klein Surgical Systems, Inc. | 2023-07-17 |
| 10850048763224 | Klein Surgical | Klein Surgical Systems, Inc. | 2023-07-17 |
| 10850048763217 | Klein Surgical | Klein Surgical Systems, Inc. | 2023-07-17 |
| 10850048763200 | Klein Surgical | Klein Surgical Systems, Inc. | 2023-07-17 |
| 10850048763194 | Klein Surgical | Klein Surgical Systems, Inc. | 2023-07-17 |
| 30884521164820 | SurgiSleeve | Covidien LP | 2016-09-24 |
| 20884521164816 | SurgiSleeve | Covidien LP | 2016-09-24 |
| 30884521164837 | SurgiSleeve | Covidien LP | 2016-09-24 |
| 10884523000948 | Endo Catch II | Covidien LP | 2016-09-24 |
| 20884523000952 | Endo Catch Gold | Covidien LP | 2016-09-24 |
| 20884523000945 | Endo Catch II | Covidien LP | 2016-09-24 |
| 10884523000955 | Endo Catch Gold | Covidien LP | 2016-09-24 |