The following data is part of a premarket notification filed by Uro-1, Inc. with the FDA for Repris Bladder Injection System.
| Device ID | K180214 |
| 510k Number | K180214 |
| Device Name: | Repris Bladder Injection System |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | URO-1, Inc. 391 Technology Way Suite 168 Winston Salem, NC 27101 |
| Contact | Thomas Lawson |
| Correspondent | Thomas Lawson URO-1, Inc. 391 Technology Way Suite 168 Winston Salem, NC 27101 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-25 |
| Decision Date | 2018-05-03 |
| Summary: | summary |