The following data is part of a premarket notification filed by Uroviu Corporation with the FDA for Uro-n Cystoscope.
| Device ID | K182876 |
| 510k Number | K182876 |
| Device Name: | Uro-N Cystoscope |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | UroViu Corporation 5337 - 14th Place SE Bellevue, WA 98006 |
| Contact | Thomas Lawson |
| Correspondent | Thomas Lawson UroViu Corporation 5337 - 14th Place SE Bellevue, WA 98006 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-12 |
| Decision Date | 2019-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860008483720 | K182876 | 000 |