The following data is part of a premarket notification filed by Otu Medical Inc. with the FDA for Wiscope Om Endoscope System, Wiscope Single-use Digital Flexible Ureteroscope.choledochoscope, Wiscope Image System.
| Device ID | K210579 |
| 510k Number | K210579 |
| Device Name: | WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | OTU Medical Inc. 2231A Fortune Drive San Jose, CA 95131 |
| Contact | Geping Liu |
| Correspondent | Mingzi Hussey Zi-medical, Inc. 93 Springs Rd Bedford, MA 01730 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-26 |
| Decision Date | 2021-07-22 |