Cleared Traditional

K141674 - CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRAT...

K141674 · Integra LifeSciences Corporation · General & Plastic Surgery device
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Nov 2014
Decision
136d
Days
-
Risk

K141674 is an FDA 510(k) clearance for the CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Integra LifeSciences Corporation (Plainsboro, US). The FDA issued a Cleared decision on November 6, 2014 after a review of 136 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 Integra LifeSciences Corporation devices

Submission Details

510(k) Number K141674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2014
Decision Date November 06, 2014
Days to Decision 136 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
21d slower than avg
Panel avg: 115d · This submission: 136d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 86
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