Cleared Traditional

SINGLE USE LEE ELECTRODE

K913213 · Aspen Laboratories, Inc. · Obstetrics & Gynecology
Feb 1992
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K913213 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 Laboratories, Inc. (Englewood, US). The FDA issued a Cleared decision on February 13, 1992, 209 days after receiving the submission on July 19, 1991. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4120.

Submission Details

510(k) Number K913213 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 1991
Decision Date February 13, 1992
Days to Decision 209 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

Similar Devices — HGI Electrocautery, Gynecologic (and Accessories)

All 52
IRIS Thermocoagulator and Digital Colposcope
K202915 · Liger Medical, LLC · Apr 2021
Liger Medical HTU-110
K152843 · Liger Medical, LLC · Jun 2016
FMWAND FERROMAGNETIC SURGICAL SYSTEM
K130606 · Domain Surgical, Inc. · Jan 2014
DOMAIN SURGICAL SYSTEM
K121881 · Domain Surgical, Inc. · Oct 2012
ENDOCERVICAL ELECTRODE # 2
K070877 · Modern Medical Equipment Mfg., Ltd. · Jul 2007
FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158
K061651 · Apple Medical Corp. · Oct 2006