The following data is part of a premarket notification filed by Otu Medical Inc. with the FDA for Wiscope Digital Cystoscope System, Wiscope Single-use Digital Flexible Cystoscope, Wiscope Image System.
| Device ID | K212202 |
| 510k Number | K212202 |
| Device Name: | WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | OTU Medical INC. 2231 A Fortune Drive San Jose, CA 95131 |
| Contact | Geping Liu |
| Correspondent | Mingzi Hussey Zi-medical, Inc. 93 Springs Rd Bedford, MA 01730 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-14 |
| Decision Date | 2022-04-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850023925197 | K212202 | 000 |
| 10850023925180 | K212202 | 000 |
| 10850023925173 | K212202 | 000 |
| 10850023925166 | K212202 | 000 |