NEOTRACT, INC.

FDA Device Registration & Listing · Pleasanton, CA, US · Registration 3015181082

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015181082
FEI Number
3005791775
Entity Name
NEOTRACT, INC.
City/State/Country
Pleasanton, CA, US
Establishment Address
4155 HOPYARD ROAD, Pleasanton, CA 94588, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
NEOTRACT, INC. (Owner Number: 9088740)
Owner / Operator Contact Address
4155 HOPYARD ROAD, Pleasanton, CA 94588, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K201837
PMA Number
N/A

All Registered Proprietary Names

UroLift System UL400 UroLift System Rigid Retrieval Kit Sterilization Tray UroLift 2 System (UL500) NeoTract UroLift System (UL400) UroLift 2 ATC Advanced Tissue Control System UroLift System UL400 UroLift System Procedure Kit Sterilization Tray UroLift Advanced Tissue Control (ATC) System UroLift 2 System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PEW Implantable Transprostatic Tissue Retractor System Gastroenterology, Urology Class 2 876.5530 2020-03-20
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2021-11-24
PEW Implantable Transprostatic Tissue Retractor System Gastroenterology, Urology Class 2 876.5530 2018-01-04
PEW Implantable Transprostatic Tissue Retractor System Gastroenterology, Urology Class 2 876.5530 2023-10-27
PEW Implantable Transprostatic Tissue Retractor System Gastroenterology, Urology Class 2 876.5530 2019-05-07
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2020-06-08
PEW Implantable Transprostatic Tissue Retractor System Gastroenterology, Urology Class 2 876.5530 2020-06-08
PEW Implantable Transprostatic Tissue Retractor System Gastroenterology, Urology Class 2 876.5530 2020-08-03

Official Correspondent

Divya Raman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NEOTRACT, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243425 Talladium España, SL Guided DAS Surgical Kit 2025-07-22
K213209 K1 Medical, LLC EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device 2021-12-28
K012105 Symmetry Medical, Inc. POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM 2002-08-02
K243317 Infinitum Eta, Ltd. NUVENTUS NV.C™ Surgical Cassette and Tray 2025-02-11
K112536 Covidien SONICISION STERILIZATION TRAY 2012-04-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015181082. Last updated year: 2026. Please use registration number 3015181082 when referencing this establishment in official correspondence.
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