Cleared Traditional

K050885 - OLYMPUS ULTRASONIC SURGICAL SYSTEM SONO...

K050885 · Olympus Medical Systems Corporation · General & Plastic Surgery device
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Jun 2005
Decision
57d
Days
-
Risk

K050885 is an FDA 510(k) clearance for the OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Olympus Medical Systems Corporation (Melville, US). The FDA issued a Cleared decision on June 3, 2005 after a review of 57 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 Olympus Medical Systems Corporation devices

Submission Details

510(k) Number K050885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2005
Decision Date June 03, 2005
Days to Decision 57 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
58d faster than avg
Panel avg: 115d · This submission: 57d
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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