Cleared Traditional

K943776 - COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES (FDA 510(k) Clearance)

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

K943776 · Richard Wolf Medical Instruments Corp. · Obstetrics & Gynecology device
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Nov 1994
Decision
93d
Days
Class 2
Risk

K943776 is an FDA 510(k) clearance for the COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES. Classified as Coagulator-cutter, Endoscopic, Bipolar (and Accessories) (product code HIN), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on November 3, 1994 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4150 - 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.

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Submission Details

510(k) Number K943776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1994
Decision Date November 03, 1994
Days to Decision 93 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
67d faster than avg
Panel avg: 160d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIN Coagulator-cutter, Endoscopic, Bipolar (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4150
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.