Cleared Traditional

K880748 - BALL TIP FULGURATING ELECTRODE, 3 FRENCH

K880748 is an FDA 510(k) clearance for BALL TIP FULGURATING ELECTRODE, manufactured by Cook Urological, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K880748 · Cook Urological, Inc. · Gastroenterology & Urology device
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Aug 1988
Decision
162d
Days
Class 2
Risk

K880748 is an FDA 510(k) clearance for the BALL TIP FULGURATING ELECTRODE, 3 FRENCH. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on August 4, 1988 after a review of 162 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 Cook Urological, Inc. devices

FDA 510(k) Submission Details - K880748

510(k) Number K880748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1988
Decision Date August 04, 1988
Days to Decision 162 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
31d slower than avg
Panel avg: 131d · This submission: 162d
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 146
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K880748.
WILTEK PAPILLOTOME
K894861 · Wiltek Medical, Inc. · Dec 1989
MODEL 8800 BIPOLAR COAGULATION THERAPEUTIC SYSTEM
K892895 · Everest Medical Corp. · Sep 1989
MICROVASIVE GOLD PROBE
K885005 · Boston Scientific Corp · Feb 1989
THERMAL COAGULATOR
K870705 · Microvasive · Apr 1987
MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE
K864413 · Cooper Lasersonics, Inc. · Dec 1986
HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE
K861904 · Cooper Lasersonics, Inc. · Oct 1986