# Neotract, Inc.

- Location (FDA's records): Pleasanton, CA
- FDA decisions: 17 (2006–2023): 16 510(k) clearances and 1 De Novo grant
- Product codes: PEW (11), GAT (3), KCT (2), GAW (1)
- Predicates its devices cite: 20 (16 its own); citations of its devices by later devices: 16 (16 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Covidien: 1 (https://510kreport.com/company/covidien)
- Genzyme Corp.: 1 (https://510kreport.com/company/genzyme)
- Endogastric Solutions, Inc.: 1 (https://510kreport.com/company/endogastric-solutions)
- Onux Medical, Inc.: 1 (https://510kreport.com/company/onux-medical)

## Its most-cited devices
- K173087: UroLift System (UL400 and UL500) (2017), cited by 3
- DEN130023: Urolift System (2013), cited by 2
- K133281: Neotract Urolift System (2013), cited by 2
- K192781: UroLift System Procedure Kit Sterilization Tray (2020), cited by 1
- K193269: UroLift System (UL400) (2019), cited by 1
- K162345: UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge (2016), cited by 1

## Recent decisions
- K232558: UroLift 2 ATC Advanced Tissue Control System (Sep 22, 2023)
- K212396: UroLift System Rigid Retrieval Kit Sterilization Tray (Oct 22, 2021)
- K201837: UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge (Jul 31, 2020)
- K200441: UroLift Advanced Tissue Control (ATC) System (Jun 5, 2020)
- K192781: UroLift System Procedure Kit Sterilization Tray (Apr 14, 2020)
- K193269: UroLift System (UL400) (Dec 20, 2019)
- K190377: UroLift System UL400 (Mar 21, 2019)
- K173087: UroLift System (UL400 and UL500) (Dec 28, 2017)

Source page: https://510kreport.com/company/neotract