Cleared Traditional

K964594 - VAPORTRODE VAPORIZATION ELECTRODE -GROO...

K964594 is an FDA 510(k) clearance for VAPORTRODE VAPORIZATION ELECTRODE -GROO..., manufactured by Circon Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code KNF cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K964594 · Circon Corp. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Aug 1997
Decision
273d
Days
Class 2
Risk

K964594 is an FDA 510(k) clearance for the VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) &.... Classified as Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (product code KNF), Class II - Special Controls.

Submitted by Circon Corp. (Stamford, US). The FDA issued a Cleared decision on August 15, 1997 after a review of 273 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 Circon Corp. devices

FDA 510(k) Submission Details - K964594

510(k) Number K964594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1996
Decision Date August 15, 1997
Days to Decision 273 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 160d · This submission: 273d
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 K964594.
EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)
K010425 · Hdc Corp. · Mar 2001
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