Medical Device Manufacturer · US , Pleasanton , CA

Neotract, Inc. - FDA 510(k) Cleared Devices

17 submissions · 16 cleared · Since 2006

Recent clearances: UroLift 2 ATC Advanced Tissue Control System, UroLift System Rigid Retrieval Kit Sterilization Tray, UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge

17

Total

16

Cleared

1

Denied

FDA 510(k) Regulatory Record - Neotract, Inc. General & Plastic Surgery ✕

4 devices

1-4 of 4

Cleared Aug 04, 2010

NEOTRACT ANCHOR SYSTEM MODEL TAS400

General & Plastic Surgery · 16d

Cleared Jul 15, 2010

NEOTRACT ANCHOR SYSTEM MODEL: REF 11208

General & Plastic Surgery · 72d

Cleared Feb 01, 2008

NEOTRACT ANCHOR SYSTEM

General & Plastic Surgery · 37d

Cleared Oct 26, 2006

NEOTRACT ANCHOR

General & Plastic Surgery · 132d