Cleared Traditional

Tenex Health TX System with the TXP MicroTip (K181367) - FDA 510(k) Clearance

K181367 · Tenex Health, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Aug 2018
Decision
97d
Days
-
Risk

K181367 is an FDA 510(k) clearance for the Tenex Health TX System with the TXP MicroTip. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Tenex Health, Inc. (Lake Forest,, US). The FDA issued a Cleared decision on August 28, 2018 after a review of 97 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Tenex Health, Inc. devices

Submission Details

510(k) Number K181367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2018
Decision Date August 28, 2018
Days to Decision 97 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 115d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

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