BOOTY ENDOSCOPE WARMER
FDA 510(k) clearance K933515 · decided 1993-10-27
Clearance details
- K-number
- K933515
- Device name
- BOOTY ENDOSCOPE WARMER
- Applicant
- T-Med, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-07-20
- Decision date
- 1993-10-27
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- GCI
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR (K021747) | Surgicon, Inc. | 2002-08-15 |
| MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (K003222) | Computer Motion, Inc. | 2000-11-03 |
| KARL STORZ 3D VIDEO SYSTEM (K001362) | Karl Storz Imaging, Inc. | 2000-07-17 |
| BIRTCHER SURE CLEAN INSTRUMENT SYSTEM (K930302) | Birtcher Medical Systems, Inc. | 1993-10-27 |
| GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS (K930496) | Birtcher Medical Systems, Inc. | 1993-04-20 |
| AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH (K922123) | United States Surgical, A Division of Tyco Healthc | 1993-02-01 |
| GLEESON CLOT-BUSTER (K920139) | Conmedcorp | 1992-04-15 |
| POOLE TIP SUCTION PROBE (K915762) | O.R. Concepts, Inc. | 1992-03-13 |
| SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT (K914120) | Conmedcorp | 1991-10-30 |
| ENDOSTAPLE (K911829) | ETHICON, Inc. | 1991-08-28 |
| ENDOSCOPE AND ACCESSORIES (K905117) | Northgate Technologies, Inc. | 1991-04-25 |
| SURGITRON (K911461) | Ellman Intl. Mfg., Inc. | 1991-04-25 |
Recalls involving this device
No recalls on record reference this clearance.