Tenex Health TX System

FDA 510(k) K153299 · Tenex Health, Inc.

Substantially Equivalent

510(k) numberK153299

Submission

Device name
Tenex Health TX System
Applicant
Tenex Health, Inc.
Lake Forest,, CA, US
Received
November 13, 2015
Decision date
March 3, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LFL – Instrument, Ultrasonic Surgical
Device class
Unclassified

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K230427CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional Integra LifeSciences Corporation07/11/2023SE
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Questions and answers

When was Tenex Health TX System cleared by the FDA?

Tenex Health TX System (K153299) received a 510(k) decision of Substantially Equivalent on March 3, 2016, 111 days after the submission was received.

What is the product code of K153299?

The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.