The following data is part of a premarket notification filed by Clearpath Surgical, Inc. with the FDA for Unicare System, Unicare Manipulator.
| Device ID | K163214 |
| 510k Number | K163214 |
| Device Name: | Unicare System, Unicare Manipulator |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | ClearPath Surgical, Inc. 1052 High Street Palo Alto, CA 94301 |
| Contact | Puja Ohlhaver |
| Correspondent | Puja Ohlhaver ClearPath Surgical, Inc. 1052 High Street Palo Alto, CA 94301 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-16 |
| Decision Date | 2017-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B248100041 | K163214 | 000 |
| B248100040 | K163214 | 000 |