The following data is part of a premarket notification filed by Prescient Surgical, Inc. with the FDA for Cleancision Wound Retraction And Protection System.
| Device ID | K172132 |
| 510k Number | K172132 |
| Device Name: | CleanCision Wound Retraction And Protection System |
| Classification | Wound Retraction And Protection System |
| Applicant | Prescient Surgical, Inc. 1585 Industrial Rd. San Carlos, CA 94070 |
| Contact | Lisa Claude |
| Correspondent | Lisa Claude Prescient Surgical, Inc. 1585 Industrial Rd. San Carlos, CA 94070 |
| Product Code | PQI |
| CFR Regulation Number | 878.4371 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-14 |
| Decision Date | 2017-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28685320003014 | K172132 | 000 |
| 28685320003007 | K172132 | 000 |