Cleared Traditional

K031305 - OLYMPUS ULTRASONIC SURGICAL SYSTEM

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

FDA 510(k) Submission Details - K031305

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.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 89
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K031305.
OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG
K050885 · Olympus Medical Systems Corporation · Jun 2005
HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P
K051036 · Ethicon Endo-Surgery, Inc. · Jun 2005
HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P
K042777 · Ethicon Endo-Surgery, Inc. · Dec 2004
ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145
K012176 · Ethicon Endo-Surgery, Inc. · Oct 2001
ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145
K010898 · Ethicon Endo-Surgery, Inc. · May 2001
ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07
K002906 · Ethicon Endo-Surgery, Inc. · Dec 2000