The following data is part of a premarket notification filed by Neotract, Inc. with the FDA for Urolift 2 System (formerly Ul500), Urolift 2 Delivery Handle, Urolift 2 Implant Cartridge.
Device ID | K201837 |
510k Number | K201837 |
Device Name: | UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge |
Classification | Implantable Transprostatic Tissue Retractor System |
Applicant | NeoTract, Inc. 4155 Hopyard Road Pleasanton, CA 94588 |
Contact | Brian Gall |
Correspondent | Brian Gall NeoTract, Inc. 4155 Hopyard Road 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 | 2020-07-02 |
Decision Date | 2020-07-31 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20814932020135 | K201837 | 000 |
20814932020128 | K201837 | 000 |
10814932020206 | K201837 | 000 |
20814932020296 | K201837 | 000 |
20814932020289 | K201837 | 000 |
20814932020357 | K201837 | 000 |
20814932020340 | K201837 | 000 |
10814932021470 | K201837 | 000 |
20814932020449 | K201837 | 000 |