Cleared Traditional

OLYMPUS ULTRASONIC SURGICAL SYSTEM (K031305) - FDA 510(k) Clearance

K031305 · Olympus Optical Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
152d
Days
-
Risk

K031305 is an FDA 510(k) clearance for the OLYMPUS ULTRASONIC SURGICAL SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Olympus Optical Co., Ltd. (Melville, US). The FDA issued a Cleared decision on September 23, 2003 after a review of 152 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 Olympus Optical Co., Ltd. devices

Submission Details

510(k) Number K031305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2003
Decision Date September 23, 2003
Days to Decision 152 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
37d slower than avg
Panel avg: 115d · This submission: 152d
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 K031305.
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