Cleared Traditional

K050885 - OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG (FDA 510(k) Clearance)

K050885 · Olympus Medical Systems Corporation · General & Plastic Surgery device

Jun 2005

Decision

57d

Days

—

Risk

K050885 is an FDA 510(k) clearance for the OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG. This device is classified as a Instrument, Ultrasonic Surgical.

Submitted by Olympus Medical Systems Corporation (Melville, US). The FDA issued a Cleared decision on June 3, 2005, 57 days after receiving the submission on April 7, 2005.

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

Submission Details

510(k) Number	K050885 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 07, 2005
Decision Date	June 03, 2005
Days to Decision	57 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF