Cleared Traditional

K974168 - COOPERSURGICAL INFRARED COAGULATOR

K974168 is an FDA 510(k) clearance for COOPERSURGICAL INFRARED COAGULATOR, manufactured by Hogan & Hartson. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K974168 · Hogan & Hartson · Gastroenterology & Urology device
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Jan 1998
Decision
79d
Days
Class 2
Risk

K974168 is an FDA 510(k) clearance for the COOPERSURGICAL INFRARED COAGULATOR. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Hogan & Hartson (Washington, US). The FDA issued a Cleared decision on January 23, 1998 after a review of 79 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hogan & Hartson devices

FDA 510(k) Submission Details - K974168

510(k) Number K974168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1997
Decision Date January 23, 1998
Days to Decision 79 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 130d · This submission: 79d
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 116
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K974168.
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SPHINCTEROTOME
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K972674 · Wilson-Cook Medical, Inc. · Aug 1997
ANGLED TIP POLYPECTOMY SNARE
K970945 · United States Endoscopy Group, Inc. · May 1997