Cleared Special

K994166 - GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESE...

K994166 is an FDA 510(k) clearance for GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESE..., 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 18-day FDA review.

K994166 · Gyrus Medical , Ltd. · Gastroenterology & Urology device
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Dec 1999
Decision
18d
Days
Class 2
Risk

K994166 is an FDA 510(k) clearance for the GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE. 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 27, 1999 after a review of 18 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 - K994166

510(k) Number K994166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1999
Decision Date December 27, 1999
Days to Decision 18 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
112d faster than avg
Panel avg: 130d · This submission: 18d
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 K994166.
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K990850 · CooperSurgical, Inc. · Jun 1999
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K990855 · CooperSurgical, Inc. · Mar 1999