WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT
FDA 510(k) clearance K951519 · decided 1995-06-14
Clearance details
- K-number
- K951519
- Device name
- WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT
- Applicant
- Wells Johnson Co.
- Decision
- Substantially Equivalent
- Date received
- 1995-04-03
- Decision date
- 1995-06-14
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- FWL
- Device class
- 1
- Regulation number
- 878.4160
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Tucson, AZ, 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 |
|---|---|---|
| STORZ MODEL 62 ENT CAMERA SYSTEM (K883760) | Storz Instrument Co. | 1988-09-28 |
Recalls involving this device
No recalls on record reference this clearance.