The following data is part of a premarket notification filed by Neotract, Inc. with the FDA for Urolift Advanced Tissue Control (atc) System.
Device ID | K200441 |
510k Number | K200441 |
Device Name: | UroLift Advanced Tissue Control (ATC) System |
Classification | Implantable Transprostatic Tissue Retractor System |
Applicant | NeoTract, Inc. 4155 Hopyard Rd. Pleasanton, CA 94588 |
Contact | Brian Gall |
Correspondent | Brian Gall NeoTract, Inc. 4155 Hopyard Rd. 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 | 2020-02-24 |
Decision Date | 2020-06-05 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20814932020142 | K200441 | 000 |
20814932020401 | K200441 | 000 |