510(k) K232558
- Device
- UroLift 2 ATC Advanced Tissue Control System
- Applicant
- Neotract, Inc.
- 510(k) number
- K232558
- Product code
- PEW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-22
- Date received
- 2023-08-23
- Regulation
- 876.5530
- Classification name
- Implantable Transprostatic Tissue Retractor System
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kelsey Krische
- Address
- 4155 Hopyard Rd. Pleasanton CA US 94588 94588
FDA Registration Numbers#
- 3002907620
- 3015181082
- 3010220595
- 3010041511
- 2953359
- 3009307931
- 2029275
- 3003898360
- 3011137372
Source Documents#
Other 510(k) Records For Product Code PEW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201837 | UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge | Neotract, Inc. | 2020-07-31 |
| K200441 | UroLift Advanced Tissue Control (ATC) System | Neotract, Inc. | 2020-06-05 |
| K193269 | UroLift System (UL400) | Neotract, Inc. | 2019-12-20 |
| K190377 | UroLift System UL400 | Neotract, Inc. | 2019-03-21 |
| K173087 | UroLift System (UL400 and UL500) | Neotract, Inc. | 2017-12-28 |
| K172359 | UroLift System (UL500) | Neotract, Inc. | 2017-08-18 |
| K162345 | UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge | Neotract, Inc. | 2016-09-21 |
| K153584 | NeoTract UroLift System UL500 | Neotract, Inc. | 2016-03-15 |
| K133281 | NEOTRACT UROLIFT SYSTEM | Neotract, Inc. | 2013-12-20 |
| DEN130023 | UROLIFT SYSTEM | Neotract, Inc. | 2013-09-13 |