The following data is part of a premarket notification filed by Clinical Innovations, Inc. with the FDA for Clearview Uterine Manipulator.
| Device ID | K940681 |
| 510k Number | K940681 |
| Device Name: | CLEARVIEW UTERINE MANIPULATOR |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | CLINICAL INNOVATIONS, INC. 6477 SOUTH COTTONWOOD ST. Murray, UT 84107 |
| Contact | William Dean Wallace |
| Correspondent | William Dean Wallace CLINICAL INNOVATIONS, INC. 6477 SOUTH COTTONWOOD ST. Murray, UT 84107 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-10 |
| Decision Date | 1994-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20814247020608 | K940681 | 000 |
| 20814247020486 | K940681 | 000 |
| 20814247020479 | K940681 | 000 |
| 10814247020144 | K940681 | 000 |
| 00814247020130 | K940681 | 000 |
| 20814247020011 | K940681 | 000 |