TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL.
FDA 510(k) clearance K864960 · decided 1987-02-10
Clearance details
- K-number
- K864960
- Device name
- TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL.
- Applicant
- Cooper Lasersonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-22
- Decision date
- 1987-02-10
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- GCQ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Santa Clara, CA, 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 |
|---|---|---|
| CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340) (K920979) | Codman & Shurtleff, Inc. | 1993-03-23 |
| MEDILASE SERIES 2100 ENDOSCOPE (K900894) | Medical Laser, Inc. | 1990-06-22 |
| CODMAN FLEXIBLE ENDOSCOPE (K871978) | Codman & Shurtleff, Inc. | 1987-08-25 |
| VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE (K860771) | Van-Tec, Inc. | 1986-04-23 |
Recalls involving this device
No recalls on record reference this clearance.