The following data is part of a premarket notification filed by Neotract, Inc. with the FDA for Urolift System Ul400.
| Device ID | K190377 |
| 510k Number | K190377 |
| Device Name: | UroLift System UL400 |
| Classification | Implantable Transprostatic Tissue Retractor System |
| Applicant | NeoTract, Inc. 4473 Willow Road, Suite 100 Pleasanton, CA 94588 |
| Contact | Brian Gall |
| Correspondent | Brian Gall NeoTract, Inc. 4473 Willow Road, Suite 100 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 | 2019-02-19 |
| Decision Date | 2019-03-21 |