Neotract Inc
FDA Regulatory Profile
Neotract Inc appears in FDA public data with 2 recalls, 17 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1502-2022, Class II) was initiated on June 24, 2022. Its most recent 510(k) clearance was granted on September 22, 2023.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 17
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1502-2022 | Class II | UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool | June 24, 2022 |
| Z-0598-2019 | Class II | UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool | July 6, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K232558 | UroLift 2 ATC Advanced Tissue Control System | September 22, 2023 |
| K212396 | UroLift System Rigid Retrieval Kit Sterilization Tray | October 22, 2021 |
| K201837 | UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge | July 31, 2020 |
| K200441 | UroLift Advanced Tissue Control (ATC) System | June 5, 2020 |
| K192781 | UroLift System Procedure Kit Sterilization Tray | April 14, 2020 |
| K193269 | UroLift System (UL400) | December 20, 2019 |
| K190377 | UroLift System UL400 | March 21, 2019 |
| K173087 | UroLift System (UL400 and UL500) | December 28, 2017 |
| K172359 | UroLift System (UL500) | August 18, 2017 |
| K162345 | UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge | September 21, 2016 |
| K153584 | NeoTract UroLift System UL500 | March 15, 2016 |
| K133281 | NEOTRACT UROLIFT SYSTEM | December 20, 2013 |
| DEN130023 | UROLIFT SYSTEM | September 13, 2013 |
| K102028 | NEOTRACT ANCHOR SYSTEM MODEL TAS400 | August 4, 2010 |
| K101252 | NEOTRACT ANCHOR SYSTEM MODEL: REF 11208 | July 15, 2010 |
| K073651 | NEOTRACT ANCHOR SYSTEM | February 1, 2008 |
| K061700 | NEOTRACT ANCHOR | October 26, 2006 |