The following data is part of a premarket notification filed by Neotract, Inc. with the FDA for Urolift System Ul500, Urolift Delivery Handle, Urolift Implant Cartiridge.
| Device ID | K162345 |
| 510k Number | K162345 |
| Device Name: | UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge |
| Classification | Implantable Transprostatic Tissue Retractor System |
| Applicant | NEOTRACT, INC. 4473 WILLOW ROAD, SUITE 100 Pleasanton, CA 94588 |
| Contact | Louis-pierre Marcoux |
| Correspondent | Louis-pierre Marcoux 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 | 2016-08-22 |
| Decision Date | 2016-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10814932020022 | K162345 | 000 |