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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 161d · 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 44
Devices cleared under the same product code (KNF) and FDA review panel - the closest regulatory comparables to K022979.
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K070315 · Lina Medical Aps · Oct 2007
AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY
K010752 · Aesculap, Inc. · Jun 2001
ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO
K003405 · Highland / Marietta, Inc. · May 2001
EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)
K010425 · Hdc Corp. · Mar 2001
K022979 · LAPARETTE, MODEL LAP J L S H N
Download PDF FDA Summary Instruments Medicaux …