Cleared Traditional

K100597 - HARMONIC FOCUS SHEARS (FDA 510(k) Clearance)

K100597 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery device

Apr 2010

Decision

36d

Days

—

Risk

K100597 is an FDA 510(k) clearance for the HARMONIC FOCUS SHEARS. This device is classified as a Instrument, Ultrasonic Surgical.

Submitted by Ethicon Endo-Surgery, LLC (Cincinnati, US). The FDA issued a Cleared decision on April 7, 2010, 36 days after receiving the submission on March 2, 2010.

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

Submission Details

510(k) Number	K100597 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 02, 2010
Decision Date	April 07, 2010
Days to Decision	36 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF