The following data is part of a premarket notification filed by Neotract, Inc. with the FDA for Neotract Urolift System Ul500.
| Device ID | K153584 |
| 510k Number | K153584 |
| Device Name: | NeoTract UroLift System UL500 |
| Classification | Implantable Transprostatic Tissue Retractor System |
| Applicant | NeoTract, Inc. 4473 Willow Road, Suite 100 Pleasanton, CA 94588 |
| Contact | Nancy E Isaac |
| Correspondent | Nancy E Isaac NeoTract, Inc. 4473 Willow Road, Suite 100 Pleasanton, CA 94588 |
| Product Code | PEW |
| CFR Regulation Number | 876.5530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-15 |
| Decision Date | 2016-03-15 |
| Summary: | summary |