Cleared Traditional

K182809 - CUSA Clarity Ultrasonic Surgical Aspira...

K182809 · Integra LifeSciences Corporation · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 2018
Decision
65d
Days
-
Risk

K182809 is an FDA 510(k) clearance for the CUSA Clarity Ultrasonic Surgical Aspirator System. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on December 7, 2018 after a review of 65 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 LifeSciences Corporation devices

Submission Details

510(k) Number K182809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2018
Decision Date December 07, 2018
Days to Decision 65 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
50d faster than avg
Panel avg: 115d · This submission: 65d
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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