Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Boston ScientificLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list NeoTract, Inc. with 16 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Sep 22, 2023: UroLift 2 ATC Advanced Tissue Control System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 22, 2023 | UroLift 2 ATC Advanced Tissue Control SystemK232558 · PEW | 510(k) clearances |
| Jun 24, 2022 | UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release ToolClass II · There is the potential that during implant deployment, the device may not properly deliver a implant. | Device recalls |
| Oct 22, 2021 | UroLift System Rigid Retrieval Kit Sterilization TrayK212396 · KCT | 510(k) clearances |
| Jul 31, 2020 | UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgeK201837 · PEW | 510(k) clearances |
| Jun 5, 2020 | UroLift Advanced Tissue Control (ATC) SystemK200441 · PEW | 510(k) clearances |
| Apr 14, 2020 | UroLift System Procedure Kit Sterilization TrayK192781 · KCT | 510(k) clearances |
| Dec 20, 2019 | UroLift System (UL400)K193269 · PEW | 510(k) clearances |
| Mar 21, 2019 | UroLift System UL400K190377 · PEW | 510(k) clearances |
| Jul 6, 2018 | UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neClass II · Upon implant deployment, the Capsular Tab may not be delivered as the needle is retracted. In this failure mode, the ne | Device recalls |
| Dec 28, 2017 | UroLift System (UL400 and UL500)K173087 · PEW | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
