Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2243842

FEI Number

2243842

Entity Name

ENDO USA

City/State/Country

Cranbury, NJ, US

Establishment Address

8 CLARKE DR., Cranbury, NJ 08512, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Endo USA (Owner Number: 10029421)

Owner / Operator Contact Address

9 Great Valley Parkway, Malvern, PA 19355, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Model 001 9 Gauge Disposable Trocar with Blunt Pusher (50134) TestoPak

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2009-05-13

Official Correspondent

Robert Widergren

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Endo USA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2243842. Last updated year: 2026. Please use registration number 2243842 when referencing this establishment in official correspondence.