UroLift System (UL400 and UL500)— 510(k) K173087
Substantially EquivalentNeotract, Inc.
FDA 510(k) clearance K173087 for UroLift System (UL400 and UL500), Substantially Equivalent on 2017-12-28. Applicant: Neotract, Inc.. Device class: 2.
Clearance details
- Applicant
- Neotract, Inc.
- Product code
- Code PEW
- Device class
- Class 2
- Regulation
- 21 CFR 876.5530
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code PEW
view allMore clearances from Neotract, Inc.
view allAdverse 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 →
Recalls naming K173087
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173087.
Data sourced from openFDA. This site is unofficial and independent of the FDA.