Data / Medical devices / United States / Neotract, Inc.
Neotract, Inc.: FDA-registered device maker in Pleasanton, CA, United States, 8 510(k) clearances
Neotract, Inc. is registered with the FDA (registration 3015181082) in Pleasanton, CA, United States. It lists 2 device types. The FDA files 8 510(k) clearances under its listings, the newest dated September 22, 2023. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015181082
- FEI number
- 3005791775
- Address
- 4155 Hopyard Road, Pleasanton, CA, United States, 94588
- Owner or operator
- NEOTRACT, INC. (9088740)
- Roles
- Specification developer
- First device listed
- January 4, 2018
- Registered through
- 2026
- Brand names listed
- NeoTract UroLift System (UL400), UroLift 2 ATC Advanced Tissue Control System, UroLift 2 System, UroLift 2 System (UL500), UroLift Advanced Tissue Control (ATC) System, UroLift System Procedure Kit Sterilization Tray, UroLift System Rigid Retrieval Kit Sterilization Tray, UroLift System UL400
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Implantable Transprostatic Tissue Retractor System | PEW | 2 | Specification developer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 22, 2023 | K232558 | UroLift 2 ATC Advanced Tissue Control System | PEW | Substantially Equivalent | Neotract, Inc. | accessdata.fda.gov |
| October 22, 2021 | K212396 | UroLift System Rigid Retrieval Kit Sterilization Tray | KCT | Substantially Equivalent | Neotract, Inc. | accessdata.fda.gov |
| July 31, 2020 | K201837 | UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge | PEW | Substantially Equivalent | Neotract, Inc. | accessdata.fda.gov |
| June 5, 2020 | K200441 | UroLift Advanced Tissue Control (ATC) System | PEW | Substantially Equivalent | Neotract, Inc. | accessdata.fda.gov |
| April 14, 2020 | K192781 | UroLift System Procedure Kit Sterilization Tray | KCT | Substantially Equivalent | Neotract, Inc. | accessdata.fda.gov |
| December 20, 2019 | K193269 | UroLift System (UL400) | PEW | Substantially Equivalent | Neotract, Inc. | accessdata.fda.gov |
| March 21, 2019 | K190377 | UroLift System UL400 | PEW | Substantially Equivalent | Neotract, Inc. | accessdata.fda.gov |
| December 28, 2017 | K173087 | UroLift System (UL400 and UL500) | PEW | Substantially Equivalent | Neotract, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 24, 2022 | 90548 | Class II | Ongoing | UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool | There is the potential that during implant deployment, the device may not properly deliver a implant. | accessdata.fda.gov |
| July 6, 2018 | 81576 | Class II | Terminated | UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract | Upon implant deployment, the Capsular Tab may not be delivered as the needle is retracted. In this failure mode, the needle is deployed into the prostate and retracted, leaving no implant behind. Failure to deliver a capsular tab may result in a delay in completing a treatment or an inability to complete a treatment for the patient. Use of a recalled device | accessdata.fda.gov |
Compare with other makers
- All makers of Implantable Transprostatic Tissue Retractor System
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Updated September 22, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.