CLARUS MODEL 5197 SIGHTLITE
FDA 510(k) clearance K971455 · decided 1997-05-20
Clearance details
- K-number
- K971455
- Device name
- CLARUS MODEL 5197 SIGHTLITE
- Applicant
- Clarus Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-04-21
- Decision date
- 1997-05-20
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- FTI
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Minneapolis, MN, 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 |
|---|---|---|
| OXFORD OPTRONIX MPM 3S (K914397) | Dia-Stron, Ltd. | 1992-11-16 |
Recalls involving this device
No recalls on record reference this clearance.