The following data is part of a premarket notification filed by Neotract, Inc. with the FDA for Urolift System (ul400).
| Device ID | K193269 |
| 510k Number | K193269 |
| Device Name: | UroLift System (UL400) |
| Classification | Implantable Transprostatic Tissue Retractor System |
| Applicant | Neotract, Inc. 4155 Hopyard Rd. Pleasanton, CA 94588 |
| Contact | Brian Gall |
| Correspondent | Brian Gall Neotract, Inc. 4155 Hopyard Rd. Pleasanton, CA 94588 |
| Product Code | PEW |
| CFR Regulation Number | 876.5530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-26 |
| Decision Date | 2019-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20814932020159 | K193269 | 000 |
| 20814932020210 | K193269 | 000 |
| 20814932020395 | K193269 | 000 |