510(k) K172132
- Device
- CleanCision Wound Retraction And Protection System
- Applicant
- Prescient Surgical, Inc.
- 510(k) number
- K172132
- Product code
- PQI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-10-25
- Date received
- 2017-07-14
- Regulation
- 878.4371
- Classification name
- Wound Retraction And Protection System
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Lisa Claude
- Address
- 1585 Industrial Rd. San Carlos CA US 94070 94070
FDA Registration Numbers#
- 2031093
- 2024311
Source Documents#
Other 510(k) Records For Product Code PQI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN150038 | CleanCisionTM Wound Retraction and Protection System | Prescient Surgical | 2016-12-16 |
Legacy Summary#
summary
FDA Review#
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