Cleared Traditional

K971146 - LAPARETTE

K971146 is an FDA 510(k) clearance for LAPARETTE, manufactured by Rd Chus, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code KNF cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K971146 · Rd Chus, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Aug 1997
Decision
150d
Days
Class 2
Risk

K971146 is an FDA 510(k) clearance for the LAPARETTE. Classified as Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (product code KNF), Class II - Special Controls.

Submitted by Rd Chus, Inc. (North Attleboro, US). The FDA issued a Cleared decision on August 25, 1997 after a review of 150 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.

View all Rd Chus, Inc. devices

FDA 510(k) Submission Details - K971146

510(k) Number K971146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1997
Decision Date August 25, 1997
Days to Decision 150 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
10d faster than avg
Panel avg: 160d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 34
Devices cleared under the same product code (KNF) and FDA review panel - the closest regulatory comparables to K971146.
VAPORIZATION ELECTRODES
K970961 · Richard Wolf Medical Instruments Corp. · Apr 1998
ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS
K972856 · Rocket Medical Plc · Feb 1998
MICRO ELECTRODES
K971838 · CooperSurgical, Inc. · Nov 1997
VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG)
K964594 · Circon Corp. · Aug 1997
RESISTICK SOLID LAPAROSCOPIC ELECTRODES
K971621 · Aaron Medical Industries · Jun 1997
FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU
K964441 · Gynecare Innovation Center · Mar 1997