Cleared Traditional

K942986 - ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP)

K942986 is an FDA 510(k) clearance for ELECTRODES (BLADE, manufactured by Aaron Medical Industries. The device is a Class 2 Obstetrics & Gynecology device with product code HGI cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K942986 · Aaron Medical Industries · Obstetrics & Gynecology device
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Mar 1995
Decision
293d
Days
Class 2
Risk

K942986 is an FDA 510(k) clearance for the ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP). Classified as Electrocautery, Gynecologic (and Accessories) (product code HGI), Class II - Special Controls.

Submitted by Aaron Medical Industries (St. Petersburg, US). The FDA issued a Cleared decision on March 21, 1995 after a review of 293 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4120 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K942986

510(k) Number K942986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1994
Decision Date March 21, 1995
Days to Decision 293 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 161d · This submission: 293d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGI Device Classification - Class 2, Special Controls

Product Code HGI Electrocautery, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HGI Electrocautery, Gynecologic (and Accessories)

All 52
Devices cleared under the same product code (HGI) and FDA review panel - the closest regulatory comparables to K942986.
LEEP SYSTEM 1000
K952483 · CooperSurgical, Inc. · Oct 1995
SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE
K944450 · Unimed Surgical Products, Inc. · Jul 1995
WALLACH LEAP 100 ELECTRO SURGERY SYSTEM
K921791 · Wallach Surgical Devices, Inc. · May 1995
ELECTROSURGICAL LOOP ELECTRODE
K940191 · National Wire & Stamping, Inc. · Dec 1994
FINESSE IEC/601
K941251 · Utah Medical Products, Inc. · Dec 1994
SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE
K925333 · Aspen Labs · Sep 1994
K942986 · ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP)
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