Neotract Inc

FDA Filings

This page includes the latest FDA filings for Neotract Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3012359964
• FEI Number: 3012359964
• Name: NEOTRACT, INC.
• Owner & Operator: NEOTRACT, INC.
• Contact Address: 4155 HOPYARD ROAD ; Pleasanton CA 94588 US
• Official Correspondent:
  • Michael P Nevares
  • x-925-4010687-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 1971 Rutan Dr ; Livermore, CA 94551 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3015181082
• FEI Number: 3015181082
• Name: NEOTRACT, INC.
• Owner & Operator: NEOTRACT, INC.
• Contact Address: 4155 HOPYARD ROAD ; Pleasanton CA 94588 US
• Official Correspondent:
  • Michael P Nevares
  • x-925-4010687-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 4155 HOPYARD ROAD ; Pleasanton, CA 94588 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K212396 NeoTract, Inc.	UroLift System Rigid Retrieval Kit Sterilization Tray	2021-10-22
PMN K201837 NeoTract, Inc.	UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge	2020-07-31
PMN K200441 NeoTract, Inc.	UroLift Advanced Tissue Control (ATC) System	2020-06-05
PMN K192781 NeoTract, Inc.	UroLift System Procedure Kit Sterilization Tray	2020-04-14
PMN K193269 | PEW NEOTRACT, INC.	UroLift System UL400	2020-03-20
PMN K193269 | PEW NEOTRACT, INC.	UroLift System UL400	2020-03-20
PMN K193269 Neotract, Inc.	UroLift System (UL400)	2019-12-20
GUDID 10814932020022 NEOTRACT, INC.	UroLift® 2 UL500-C	2019-11-25
PMN K190377 | PEW NEOTRACT, INC.	UroLift System UL400	2019-05-07
PMN K190377 NeoTract, Inc.	UroLift System UL400	2019-03-21
GUDID 10814932020046 NEOTRACT, INC.	UroLift UL400-4	2018-10-26
GUDID 00814932020001 NEOTRACT, INC.	UroLift UL400-4	2018-09-26
GUDID 10814932020039 NEOTRACT, INC.	UroLift® 2 UL500-H	2018-03-29
GUDID 10814932020015 NEOTRACT, INC.	UroLift® 2 UL500-H	2018-03-29
PMN K173087 | PEW NEOTRACT, INC.	UroLift 2 System (UL500)	2018-01-04
PMN K173087 | PEW NEOTRACT, INC.	NeoTract UroLift System (UL400)	2018-01-04
PMN K173087 NeoTract, Inc.	UroLift System (UL400 And UL500)	2017-12-28
PMN K172359 NeoTract, Inc.	UroLift System (UL500)	2017-08-18
PMN K162345 NEOTRACT, INC.	UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge	2016-09-21
PMN K153584 NeoTract, Inc.	NeoTract UroLift System UL500	2016-03-15
PMN K133281 NEOTRACT, INC.	NEOTRACT UROLIFT SYSTEM	2013-12-20
PMN K102028 NEOTRACT, INC.	NEOTRACT ANCHOR SYSTEM MODEL TAS400	2010-08-04
PMN K101252 NEOTRACT, INC.	NEOTRACT ANCHOR SYSTEM MODEL: REF 11208	2010-07-15
PMN K073651 NEOTRACT, INC.	NEOTRACT ANCHOR SYSTEM	2008-02-01
PMN K061700 NEOTRACT, INC.	NEOTRACT ANCHOR	2006-10-26

Related Finance Registrations

NCAGE Code	6YUV7	NEOTRACT, INC.
CAGE Code	6YUV7	NEOTRACT, INC.
SEC	0001356876	NEOTRACT INC of DELAWARE