CleanCisionTM Wound Retraction and Protection System
FDA 510(k) clearance DEN150038 · decided 2016-12-16
Clearance details
- K-number
- DEN150038
- Device name
- CleanCisionTM Wound Retraction and Protection System
- Applicant
- Prescient Surgical
- Decision
- Unknown
- Date received
- 2015-08-13
- Decision date
- 2016-12-16
- Days to decision
- 491 days
- Clearance type
- Direct
- Product code
- PQI
- Device class
- 2
- Regulation number
- 878.4371
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Carlos, 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 |
|---|---|---|
| CleanCision Wound Retraction and Protection System (K172132) | Prescient Surgical, Inc. | 2017-10-25 |
Recalls involving this device
No recalls on record reference this clearance.