Cleared Traditional

K981463 - OMNITECH RESECTOSCOPE ROLLER ELECTRODE

K981463 is an FDA 510(k) clearance for OMNITECH RESECTOSCOPE ROLLER ELECTRODE, manufactured by Omnitech Systems, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code KNF cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K981463 · Omnitech Systems, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Jul 1998
Decision
85d
Days
Class 2
Risk

K981463 is an FDA 510(k) clearance for the OMNITECH RESECTOSCOPE ROLLER ELECTRODE. Classified as Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (product code KNF), Class II - Special Controls.

Submitted by Omnitech Systems, Inc. (Valparaiso, US). The FDA issued a Cleared decision on July 17, 1998 after a review of 85 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 Omnitech Systems, Inc. devices

FDA 510(k) Submission Details - K981463

510(k) Number K981463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1998
Decision Date July 17, 1998
Days to Decision 85 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 160d · This submission: 85d
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 K981463.
LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8
K070315 · Lina Medical Aps · Oct 2007
AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY
K010752 · Aesculap, Inc. · Jun 2001
EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)
K010425 · Hdc Corp. · Mar 2001
OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE
K981464 · Omnitech Systems, Inc. · Jul 1998
VAPORIZATION ELECTRODES
K970961 · Richard Wolf Medical Instruments Corp. · Apr 1998
ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS
K972856 · Rocket Medical Plc · Feb 1998