Product code PEW— Gastroenterology, Urology
NEOTRACT UROLIFT SYSTEM
- Classification name
- Implantable Transprostatic Tissue Retractor System
- Device class
- Class 2
- Regulation
- 21 CFR 876.5530
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 11
- First cleared
- Most recent
FDA classification definition
“The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.”
Market context for product code PEW
FDA has cleared devices under product code PEW between 2013 and 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2023
- 2020
- 2019
- 2017
- 2016
- 2013
Top applicants under product code PEW
Adverse events under product code PEW
product code PEW- Death
- 7
- Injury
- 161
- Total
- 168
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code PEW
- K232558 — UroLift 2 ATC Advanced Tissue Control System
- K201837 — UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge
- K200441 — UroLift Advanced Tissue Control (ATC) System
- K193269 — UroLift System (UL400)
- K190377 — UroLift System UL400
- K173087 — UroLift System (UL400 and UL500)
- K172359 — UroLift System (UL500)
- K162345 — UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge
- K153584 — NeoTract UroLift System UL500
- K133281 — NEOTRACT UROLIFT SYSTEM
- DEN130023 — UROLIFT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.