M-LENS (THIRTY DEGREE ENDOSCOPE)
FDA 510(k) clearance K873795 · decided 1988-01-14
Clearance details
- K-number
- K873795
- Device name
- M-LENS (THIRTY DEGREE ENDOSCOPE)
- Applicant
- Opto Vision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-09-17
- Decision date
- 1988-01-14
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- FEI
- Device class
- 1
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Chicago, IL, 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 |
|---|---|---|
| FLEXIBLE VISUALIZATION CATHETER (K862872) | American Edwards Laboratories | 1986-10-24 |
Recalls involving this device
No recalls on record reference this clearance.