Cleared Traditional

SINGLE USE LAPARSCOPIC ELECTRODE

K904240 · Aspen Labs · Obstetrics & Gynecology

Feb 1991

Decision

159d

Days

Class 2

Risk

About This 510(k) Submission

K904240 is an FDA 510(k) clearance for the SINGLE USE LAPARSCOPIC ELECTRODE, a Coagulator, Laparoscopic, Unipolar (and Accessories) (Class II — Special Controls, product code HFG), submitted by Aspen Labs (Utica, US). The FDA issued a Cleared decision on February 19, 1991, 159 days after receiving the submission on September 13, 1990. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.

Submission Details

510(k) Number	K904240 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 13, 1990
Decision Date	February 19, 1991
Days to Decision	159 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—