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 |