The following data is part of a premarket notification filed by Neotract, Inc. with the FDA for Urolift System (ul400).
Device ID | K193269 |
510k Number | K193269 |
Device Name: | UroLift System (UL400) |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-11-26 |
Decision Date | 2019-12-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20814932020159 | K193269 | 000 |
20814932020210 | K193269 | 000 |
20814932020395 | K193269 | 000 |