Cianna Medical SAVI Scout Reflector and SAVI Scout System
FDA 510(k) clearance K161507 · decided 2016-07-29
Clearance details
- K-number
- K161507
- Device name
- Cianna Medical SAVI Scout Reflector and SAVI Scout System
- Applicant
- Cianna Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-06-01
- Decision date
- 2016-07-29
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- PDW
- Device class
- 2
- Regulation number
- 878.4670
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Aliso Viejo, 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 |
|---|---|---|
| MOERAE SURGICAL MARKING PEN (DEN130004) | Moerae Matrix, Inc. | 2014-12-18 |
| CIANNA MEDICAL SGS SYSTEM (K141318) | Cianna Medical, Inc. | 2014-08-27 |
Recalls involving this device
No recalls on record reference this clearance.