Cleared Traditional

K964441 - FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR...

K964441 is an FDA 510(k) clearance for FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR..., manufactured by Gynecare Innovation Center. The device is a Class 2 Obstetrics & Gynecology device with product code KNF cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K964441 · Gynecare Innovation Center · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
142d
Days
Class 2
Risk

K964441 is an FDA 510(k) clearance for the FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTI.... Classified as Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (product code KNF), Class II - Special Controls.

Submitted by Gynecare Innovation Center (Sunnyvale, US). The FDA issued a Cleared decision on March 28, 1997 after a review of 142 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 Gynecare Innovation Center devices

FDA 510(k) Submission Details - K964441

510(k) Number K964441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1996
Decision Date March 28, 1997
Days to Decision 142 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 160d · This submission: 142d
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 21
Devices cleared under the same product code (KNF) and FDA review panel - the closest regulatory comparables to K964441.
VAPORIZATION ELECTRODES
K970961 · Richard Wolf Medical Instruments Corp. · Apr 1998
MICRO ELECTRODES
K971838 · CooperSurgical, Inc. · Nov 1997
RESISTICK SOLID LAPAROSCOPIC ELECTRODES
K971621 · Aaron Medical Industries · Jun 1997
SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES
K953242 · Symbiosis Corp. · Oct 1995
KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES
K944862 · KARL STORZ Endoscopy-America, Inc. · Feb 1995
KARL STORZ MONOPOLAR COAGULATION, NEEDLE, LOOP ELECTRODES
K944793 · KARL STORZ Endoscopy-America, Inc. · Jan 1995