Cleared Traditional

K981464 - OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K981464 · Omnitech Systems, Inc. · Obstetrics & Gynecology device
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Jul 1998
Decision
78d
Days
Class 2
Risk

K981464 is an FDA 510(k) clearance for the OMNITECH RESECTOSCOPE CUTTING LOOP 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 10, 1998 after a review of 78 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

Submission Details

510(k) Number K981464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1998
Decision Date July 10, 1998
Days to Decision 78 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
82d faster than avg
Panel avg: 160d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 43
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