UroLift System (UL500)
FDA 510(k) clearance K172359 · decided 2017-08-18
Clearance details
- K-number
- K172359
- Device name
- UroLift System (UL500)
- Applicant
- Neotract, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-08-04
- Decision date
- 2017-08-18
- Days to decision
- 14 days
- Clearance type
- Special
- Product code
- PEW
- Device class
- 2
- Regulation number
- 876.5530
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| UroLift 2 ATC Advanced Tissue Control System (K232558) | Neotract, Inc. | 2023-09-22 |
| UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge (K201837) | Neotract, Inc. | 2020-07-31 |
| UroLift Advanced Tissue Control (ATC) System (K200441) | Neotract, Inc. | 2020-06-05 |
| UroLift System (UL400) (K193269) | Neotract, Inc. | 2019-12-20 |
| UroLift System UL400 (K190377) | Neotract, Inc. | 2019-03-21 |
| UroLift System (UL400 and UL500) (K173087) | Neotract, Inc. | 2017-12-28 |
| UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge (K162345) | Neotract, Inc. | 2016-09-21 |
| NeoTract UroLift System UL500 (K153584) | Neotract, Inc. | 2016-03-15 |
| NEOTRACT UROLIFT SYSTEM (K133281) | Neotract, Inc. | 2013-12-20 |
| UROLIFT SYSTEM (DEN130023) | Neotract, Inc. | 2013-09-13 |
Recalls involving this device
No recalls on record reference this clearance.