Cleared Traditional

K123640 - TX1 TISSUE REMOVAL SYSTEM

K123640 · Tenex Health · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
114d
Days
-
Risk

K123640 is an FDA 510(k) clearance for the TX1 TISSUE REMOVAL SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Tenex Health (Lake Forest,, US). The FDA issued a Cleared decision on March 20, 2013 after a review of 114 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.

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FDA 510(k) Submission Details - K123640

510(k) Number K123640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2012
Decision Date March 20, 2013
Days to Decision 114 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 115d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

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