The following data is part of a premarket notification filed by Neotract, Inc. with the FDA for Urolift System (ul400 And Ul500).
Device ID | K173087 |
510k Number | K173087 |
Device Name: | UroLift System (UL400 And UL500) |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-29 |
Decision Date | 2017-12-28 |
Summary: | summary |