Cleared Traditional

K070877 - ENDOCERVICAL ELECTRODE # 2
(FDA 510(k) Clearance)

K070877 · Modern Medical Equipment Mfg., Ltd. · Obstetrics & Gynecology

Jul 2007

Decision

120d

Days

Class 2

Risk

K070877 is an FDA 510(k) clearance for the ENDOCERVICAL ELECTRODE # 2, a Electrocautery, Gynecologic (and Accessories) (Class II — Special Controls, product code HGI), submitted by Modern Medical Equipment Mfg., Ltd. (Richmond, US). The FDA issued a Cleared decision on July 27, 2007, 120 days after receiving the submission on March 29, 2007. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4120.

Submission Details

510(k) Number	K070877 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 29, 2007
Decision Date	July 27, 2007
Days to Decision	120 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF