Cleared Traditional

K935947 - HI-TOPS ELECTRODES 14-8000

K935947 is an FDA 510(k) clearance for HI-TOPS ELECTRODES 14-8000, manufactured by W. J. Medical Instruments, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code KNF cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K935947 · W. J. Medical Instruments, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
77d
Days
Class 2
Risk

K935947 is an FDA 510(k) clearance for the HI-TOPS ELECTRODES 14-8000. Classified as Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (product code KNF), Class II - Special Controls.

Submitted by W. J. Medical Instruments, Inc. (Newbury Park, US). The FDA issued a Cleared decision on February 28, 1994 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all W. J. Medical Instruments, Inc. devices

FDA 510(k) Submission Details - K935947

510(k) Number K935947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1993
Decision Date February 28, 1994
Days to Decision 77 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
83d faster than avg
Panel avg: 160d · This submission: 77d
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 K935947.
KARL STORZ INSULATED SCISSORS
K944297 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
KARL STORZ INSULATED BIOPSY FORCEPS
K944300 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
ENDOMED LAPAROSCOPY INSTRUMENTS
K921686 · Buckman Co., Inc. · Mar 1994
REFLEX(R) ESC
K924200 · Richard-Allan Medical Ind., Inc. · Feb 1994
ELECTRO-GYNE ELECTROSURGICAL GENERATOR
K871960 · Cabot Medical Corp. · Jul 1987