CAMERA, SURGICAL AND ACCESSORIES
FDA 510(k) clearance K934092 · decided 1994-01-07
Clearance details
- K-number
- K934092
- Device name
- CAMERA, SURGICAL AND ACCESSORIES
- Applicant
- Envision Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-08-23
- Decision date
- 1994-01-07
- Days to decision
- 137 days
- Clearance type
- Traditional
- Product code
- FWB
- Device class
- 1
- Regulation number
- 878.4160
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Goleta, 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 |
|---|---|---|
| SURGICAL VIDEO CAMERA, MODEL 9500 (K902359) | Seitz Technical Products, Inc. | 1990-07-12 |
| SONY COLOR VIDEO CAMERAS AND ACCESSORIES (K884343) | Sony Corp. of America | 1988-11-01 |
| MC-SERIES SURGICAL CAMERAS (K871057) | M.P. Video, Inc. | 1987-04-03 |
| MEDICAL DYNAMICS CCD SOLID STATE VIDEO CAMERA 5930 (K855020) | Medline Industries, Inc. | 1986-01-24 |
| MEDICAM (K820829) | M.P. Video, Inc. | 1982-05-03 |
Recalls involving this device
No recalls on record reference this clearance.