FDA Product Code
FDA Product Code PEW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5530
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232558 | UroLift 2 ATC Advanced Tissue Control System | Neotract, Inc. | 2023-09-22 | Special | PDF ↗ |
| K201837 | UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge | Neotract, Inc. | 2020-07-31 | Special | PDF ↗ |
| K200441 | UroLift Advanced Tissue Control (ATC) System | Neotract, Inc. | 2020-06-05 | Traditional | PDF ↗ |
| K193269 | UroLift System (UL400) | Neotract, Inc. | 2019-12-20 | Special | PDF ↗ |
| K190377 | UroLift System UL400 | Neotract, Inc. | 2019-03-21 | Special | PDF ↗ |
| K173087 | UroLift System (UL400 and UL500) | Neotract, Inc. | 2017-12-28 | Traditional | PDF ↗ |
| K172359 | UroLift System (UL500) | Neotract, Inc. | 2017-08-18 | Special | PDF ↗ |
| K162345 | UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge | Neotract, Inc. | 2016-09-21 | Special | PDF ↗ |
| K153584 | NeoTract UroLift System UL500 | Neotract, Inc. | 2016-03-15 | Traditional | PDF ↗ |
| K133281 | NEOTRACT UROLIFT SYSTEM | Neotract, Inc. | 2013-12-20 | Special | PDF ↗ |
| DEN130023 | UROLIFT SYSTEM | Neotract, Inc. | 2013-09-13 | Direct | — |
Product code PEW · Class II · Gastroenterology, Urology. Data: openFDA.