Cleared Traditional

CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM (K081459) - FDA 510(k) Clearance

K081459 · Integra Radionics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
82d
Days
-
Risk

K081459 is an FDA 510(k) clearance for the CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Integra Radionics, Inc. (Burlington, US). The FDA issued a Cleared decision on August 13, 2008 after a review of 82 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Integra Radionics, Inc. devices

Submission Details

510(k) Number K081459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2008
Decision Date August 13, 2008
Days to Decision 82 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
33d faster than avg
Panel avg: 115d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 39
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K081459.
Tenex Health TX System with the TXP MicroTip
K181367 · Tenex Health, Inc. · Aug 2018
Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide
K180149 · Covidien, LLC · Mar 2018
Ultrasonic Generator
K172691 · Olympus Medical Systems Corp. · Oct 2017
ULTRASONIC HAND INSTRUMENTS
K971861 · United States Surgical, A Division of Tyco Healthc · Jul 1997
SUSZOI ULTRASONIC SURGICAL ASPIRATOR SONOP
K852539 · Johnson & Johnson Professionals, Inc. · Jul 1985
NEEDLE GUIDE MODEL 21285A
K830753 · Hewlett-Packard Co. · Jun 1983