Cleared Traditional

OLYMPUS SONOSURG SYSTEM (K972114) - FDA 510(k) Clearance

K972114 · The Olympus Optical Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
347d
Days
-
Risk

K972114 is an FDA 510(k) clearance for the OLYMPUS SONOSURG SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by The Olympus Optical Co. (Great Neck, US). The FDA issued a Cleared decision on May 18, 1998 after a review of 347 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 The Olympus Optical Co. devices

Submission Details

510(k) Number K972114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1997
Decision Date May 18, 1998
Days to Decision 347 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
232d slower than avg
Panel avg: 115d · This submission: 347d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 39
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