Cleared Traditional

K000095 - OLYMPUS SONOSURG TROCAR XT3900 SYSTEM

K000095 · The Olympus Optical Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
257d
Days
-
Risk

K000095 is an FDA 510(k) clearance for the OLYMPUS SONOSURG TROCAR XT3900 SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by The Olympus Optical Co. (Melville, US). The FDA issued a Cleared decision on September 26, 2000 after a review of 257 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 The Olympus Optical Co. devices

FDA 510(k) Submission Details - K000095

510(k) Number K000095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2000
Decision Date September 26, 2000
Days to Decision 257 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
142d slower than avg
Panel avg: 115d · This submission: 257d
Pathway characteristics
Predicate-based equivalence.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

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