Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009750704

FEI Number

1000135560

Entity Name

TENEX HEALTH

City/State/Country

Lake Forest, CA, US

Establishment Address

26902 Vista Terrace, Lake Forest, CA 92630, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Tenex Health (Owner Number: 10042896)

Owner / Operator Contact Address

26902 Vista Terrace, Lake Forest, CA 92630, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K123640

PMA Number

N/A

All Registered Proprietary Names

Tenex 2nd Generation Microtip TX2 Procedure Pack TX Supply Kit TX System Console TX2 MicroTip Tenex Health TX System TX1 Tissue Removal System TX Supply Kit Tenex Health TX System TX1 Procedure Pack TX1 MicroTip TX System Console

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2024-12-03
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2016-09-07
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2013-09-03

Official Correspondent

David Vancelette

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tenex Health

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0332-2022	Covidien Llc	U	Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009750704. Last updated year: 2026. Please use registration number 3009750704 when referencing this establishment in official correspondence.