Cleared Special

K022979 - LAPARETTE, MODEL LAP J L S H N

K022979 is an FDA 510(k) clearance for LAPARETTE, manufactured by Instruments Medicaux G.B., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code KNF cleared through the Special 510(k) pathway after a 100-day FDA review.

K022979 · Instruments Medicaux G.B., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
100d
Days
Class 2
Risk

K022979 is an FDA 510(k) clearance for the LAPARETTE, MODEL LAP J L S H N. Classified as Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (product code KNF), Class II - Special Controls.

Submitted by Instruments Medicaux G.B., Inc. (Sherbrooke, Quebec, CA). The FDA issued a Cleared decision on December 18, 2002 after a review of 100 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Instruments Medicaux G.B., Inc. devices

FDA 510(k) Submission Details - K022979

510(k) Number K022979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2002
Decision Date December 18, 2002
Days to Decision 100 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 160d · This submission: 100d
Pathway characteristics
Modification to existing cleared device.

KNF Device Classification - Class 2, Special Controls

Product Code KNF Coagulator-cutter, Endoscopic, 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 - KNF Coagulator-cutter, Endoscopic, Unipolar (and Accessories)

All 35
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