Cleared Traditional

K943776 - COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES

K943776 is an FDA 510(k) clearance for COAGULATOR CUTTER, manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HIN cleared through the Traditional 510(k) pathway after a 93-day FDA review.

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.

View all Richard Wolf Medical Instruments Corp. devices

FDA 510(k) Submission Details - K943776

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
Combination Product No
PCCP Authorized No
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.

HIN Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HIN Coagulator-cutter, Endoscopic, Bipolar (and Accessories)

All 14
Devices cleared under the same product code (HIN) and FDA review panel - the closest regulatory comparables to K943776.
BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771
K990147 · Richard Wolf Medical Instruments Corp. · Apr 1999
BICOAG COAGULATING FORCEPS
K971565 · Everest Medical Corp. · Mar 1998
ELMED LBC 50-P
K926517 · Elmed, Inc. · Nov 1994
STI TISSUE MANIPULATOR
K911699 · Surgical Technologies, Inc. · Jun 1991
MODEL 26021C BIPOLAR COAGULATOR
K871745 · KARL STORZ Endoscopy-America, Inc. · Jul 1987
FORCEPS, ELECTROSURGICAL
K781109 · Kli · Sep 1978