Cleared Traditional

K892895 - MODEL 8800 BIPOLAR COAGULATION THERAPEUTIC SYSTEM

K892895 is an FDA 510(k) clearance for MODEL 8800 BIPOLAR COAGULATION THERAPEU..., manufactured by Everest Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K892895 · Everest Medical Corp. · Gastroenterology & Urology device
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Sep 1989
Decision
153d
Days
Class 2
Risk

K892895 is an FDA 510(k) clearance for the MODEL 8800 BIPOLAR COAGULATION THERAPEUTIC SYSTEM. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Everest Medical Corp. (Brooklyn Center, US). The FDA issued a Cleared decision on September 25, 1989 after a review of 153 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Everest Medical Corp. devices

FDA 510(k) Submission Details - K892895

510(k) Number K892895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1989
Decision Date September 25, 1989
Days to Decision 153 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 131d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNS Device Classification - Class 2, Special Controls

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 152
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K892895.
PORGES SPHINCTEROTOMES
K896426 · Porges Corp. · Jan 1990
BITOME(TM) BIPOLAR SPHINCTEROTOME
K895842 · Everest Medical Corp. · Jan 1990
WILTEK PAPILLOTOME
K894861 · Wiltek Medical, Inc. · Dec 1989
MICROVASIVE GOLD PROBE
K885005 · Boston Scientific Corp · Feb 1989
BALL TIP FULGURATING ELECTRODE, 3 FRENCH
K880748 · Cook Urological, Inc. · Aug 1988
THERMAL COAGULATOR
K870705 · Microvasive · Apr 1987