Cleared Traditional

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

K031305 · Olympus Optical Co., Ltd. · General & Plastic Surgery device

Sep 2003

Decision

152d

Days

—

Risk

K031305 is an FDA 510(k) clearance for the OLYMPUS ULTRASONIC SURGICAL SYSTEM. This device is classified as a Instrument, Ultrasonic Surgical.

Submitted by Olympus Optical Co., Ltd. (Melville, US). The FDA issued a Cleared decision on September 23, 2003, 152 days after receiving the submission on April 24, 2003.

This device falls under the General & Plastic Surgery FDA review panel.

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