Cleared Traditional

SINGLE USE LEE ELECTRODE

K912046 · Aspen Labs · Obstetrics & Gynecology
Mar 1992
Decision
302d
Days
Class 2
Risk

About This 510(k) Submission

K912046 is an FDA 510(k) clearance for the SINGLE USE LEE ELECTRODE, a Electrocautery, Gynecologic (and Accessories) (Class II — Special Controls, product code HGI), submitted by Aspen Labs (Englewood, US). The FDA issued a Cleared decision on March 5, 1992, 302 days after receiving the submission on May 8, 1991. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4120.

Submission Details

510(k) Number K912046 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 1991
Decision Date March 05, 1992
Days to Decision 302 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

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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