ENTERIX INC.

FDA Device Registration & Listing · EDISON, NJ, US · Registration 1226769

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
1226769
FEI Number
3003224146
Entity Name
ENTERIX INC.
City/State/Country
EDISON, NJ, US
Establishment Address
236 Fernwood Ave, EDISON, NJ 08837, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
3T MEDICAL SYSTEMS, Inc (Owner Number: 9043935)
Owner / Operator Contact Address
236 Fernwood Ave, Edison, NJ 08837, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K101831
PMA Number
N/A

All Registered Proprietary Names

InSure One

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OSL Control, Fecal Occult Blood Hematology Class 2 864.6550 2024-01-03

Official Correspondent

Erica Franco

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

3T MEDICAL SYSTEMS, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1836518 3T Medical Systems Inc. Edison, NJ, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1226769. Last updated year: 2026. Please use registration number 1226769 when referencing this establishment in official correspondence.
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