Cleared Traditional

K904240 - SINGLE USE LAPARSCOPIC ELECTRODE

K904240 is an FDA 510(k) clearance for SINGLE USE LAPARSCOPIC ELECTRODE, manufactured by Aspen Labs. The device is a Class 2 Obstetrics & Gynecology device with product code HFG cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K904240 · Aspen Labs · Obstetrics & Gynecology device
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Feb 1991
Decision
159d
Days
Class 2
Risk

K904240 is an FDA 510(k) clearance for the SINGLE USE LAPARSCOPIC ELECTRODE. Classified as Coagulator, Laparoscopic, Unipolar (and Accessories) (product code HFG), Class II - Special Controls.

Submitted by Aspen Labs (Utica, US). The FDA issued a Cleared decision on February 19, 1991 after a review of 159 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4160 - 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.

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FDA 510(k) Submission Details - K904240

510(k) Number K904240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1990
Decision Date February 19, 1991
Days to Decision 159 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 160d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFG Device Classification - Class 2, Special Controls

Product Code HFG Coagulator, Laparoscopic, Unipolar (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4160
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.