Cleared Traditional

BICOAG COAGULATING FORCEPS (K971565) - FDA 510(k) Clearance

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

K971565 · Everest Medical Corp. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Mar 1998
Decision
317d
Days
Class 2
Risk

K971565 is an FDA 510(k) clearance for the BICOAG COAGULATING FORCEPS. Classified as Coagulator-cutter, Endoscopic, Bipolar (and Accessories) (product code HIN), Class II - Special Controls.

Submitted by Everest Medical Corp. (Minneapolis, US). The FDA issued a Cleared decision on March 12, 1998 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Everest Medical Corp. devices

Submission Details

510(k) Number K971565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1997
Decision Date March 12, 1998
Days to Decision 317 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 160d · This submission: 317d
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.

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

All 15
Devices cleared under the same product code (HIN) and FDA review panel - the closest regulatory comparables to K971565.
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VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS
K111751 · Ethicon, Inc. · Dec 2011
MODEL 26021C BIPOLAR COAGULATOR
K871745 · KARL STORZ Endoscopy-America, Inc. · Jul 1987