Cleared Traditional

K991424 - INSULSCAN INSULATION TESTING SYSTEM

K991424 is an FDA 510(k) clearance for INSULSCAN INSULATION TESTING SYSTEM, manufactured by Medicor Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HFG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K991424 · Medicor Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
90d
Days
Class 2
Risk

K991424 is an FDA 510(k) clearance for the INSULSCAN INSULATION TESTING SYSTEM. Classified as Coagulator, Laparoscopic, Unipolar (and Accessories) (product code HFG), Class II - Special Controls.

Submitted by Medicor Corp. (Vernon Hills, US). The FDA issued a Cleared decision on July 22, 1999 after a review of 90 days - within the typical 510(k) review window.

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.

View all Medicor Corp. devices

FDA 510(k) Submission Details - K991424

510(k) Number K991424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1999
Decision Date July 22, 1999
Days to Decision 90 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 160d · This submission: 90d
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.

Regulatory Peers - HFG Coagulator, Laparoscopic, Unipolar (and Accessories)

All 8
Devices cleared under the same product code (HFG) and FDA review panel - the closest regulatory comparables to K991424.
ACESSA GUIDANCE SYSTEM
K132744 · Halt Medical, Inc. · May 2014
ACESSA GUIDANCE HANDPIECE
K132184 · Halt Medical, Inc. · Apr 2014
THE ABLATION SYSTEM
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ENDO-TECH LTD., TIPS
K961695 · Ratio Design Lab · Jul 1996
DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP
K921405 · Davol, Inc. · Mar 1994
DAVOL ELECTROSUGICAL PROBES
K915406 · Davol, Inc. · Feb 1992