Cleared Traditional

K150682 - CUSA Excel+

K150682 · Integra Lifesciences Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
276d
Days
-
Risk

K150682 is an FDA 510(k) clearance for the CUSA Excel+. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Integra Lifesciences Corp. (Planisboro, US). The FDA issued a Cleared decision on December 18, 2015 after a review of 276 days - an extended review 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: 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 Corp. devices

Submission Details

510(k) Number K150682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2015
Decision Date December 18, 2015
Days to Decision 276 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
161d slower than avg
Panel avg: 115d · This submission: 276d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 87
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