Cleared Traditional

GYNEX ELECTRODES

K982739 · Gynex Corp. · Obstetrics & Gynecology
Mar 1999
Decision
218d
Days
Class 2
Risk

About This 510(k) Submission

K982739 is an FDA 510(k) clearance for the GYNEX ELECTRODES, a Electrocautery, Gynecologic (and Accessories) (Class II — Special Controls, product code HGI), submitted by Gynex Corp. (Pleasant Hill, US). The FDA issued a Cleared decision on March 12, 1999, 218 days after receiving the submission on August 6, 1998. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4120.

Submission Details

510(k) Number K982739 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 1998
Decision Date March 12, 1999
Days to Decision 218 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HGI — Electrocautery, Gynecologic (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4120

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