Tenex 2nd Generation System

FDA 510(k) K241700 · Trice Medical, Inc.

Substantially Equivalent

510(k) numberK241700

Submission

Device name
Tenex 2nd Generation System
Applicant
Trice Medical, Inc.
Malvern, PA, US
Received
June 13, 2024
Decision date
November 18, 2024
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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Questions and answers

When was Tenex 2nd Generation System cleared by the FDA?

Tenex 2nd Generation System (K241700) received a 510(k) decision of Substantially Equivalent on November 18, 2024, 158 days after the submission was received.

What is the product code of K241700?

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