Neotract, Inc.
Neotract, Inc. holds FDA 510(k) medical device clearances, first cleared 2006, most recent 2023, with 2 FDA device recalls on record.
Top product codes for Neotract, Inc.
FDA recalls by Neotract, Inc.
- Z-1502-2022 — UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
- Z-0598-2019 — UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Neotract, Inc.
- K232558 — UroLift 2 ATC Advanced Tissue Control System
- K212396 — UroLift System Rigid Retrieval Kit Sterilization Tray
- K201837 — UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge
- K200441 — UroLift Advanced Tissue Control (ATC) System
- K192781 — UroLift System Procedure Kit Sterilization Tray
- 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
- K102028 — NEOTRACT ANCHOR SYSTEM MODEL TAS400
- K101252 — NEOTRACT ANCHOR SYSTEM MODEL: REF 11208
- K073651 — NEOTRACT ANCHOR SYSTEM
- K061700 — NEOTRACT ANCHOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.