Cleared Traditional

THOMAS MEDICAL ELECTRODES

K022593 · Thomas Medical, Inc. · Obstetrics & Gynecology

Nov 2002

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K022593 is an FDA 510(k) clearance for the THOMAS MEDICAL ELECTRODES, a Electrocautery, Gynecologic (and Accessories) (Class II — Special Controls, product code HGI), submitted by Thomas Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on November 1, 2002, 88 days after receiving the submission on August 5, 2002. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4120.

Submission Details

510(k) Number	K022593 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 2002
Decision Date	November 01, 2002
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement