Cleared Special

K003569 - PLASMAKINETIC ENDOUROLOGY SYSTEM

K003569 is an FDA 510(k) clearance for PLASMAKINETIC ENDOUROLOGY SYSTEM, manufactured by Gyrus Medical , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Special 510(k) pathway after a 29-day FDA review.

K003569 · Gyrus Medical , Ltd. · Gastroenterology & Urology device
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Dec 2000
Decision
29d
Days
Class 2
Risk

K003569 is an FDA 510(k) clearance for the PLASMAKINETIC ENDOUROLOGY SYSTEM. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Gyrus Medical , Ltd. (Cardiff, Wales, GB). The FDA issued a Cleared decision on December 19, 2000 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Gyrus Medical , Ltd. devices

FDA 510(k) Submission Details - K003569

510(k) Number K003569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2000
Decision Date December 19, 2000
Days to Decision 29 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K003569.
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RAPID EXCHANGE TAPERTOME
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COOPERSURGICAL INFRARED COAGULATOR
K990852 · CooperSurgical, Inc. · Jun 1999
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K990850 · CooperSurgical, Inc. · Jun 1999