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 |