Cleared Special

K053322 - MODIFICATION TO: ROEI WORKING ELEMENT A...

K053322 is an FDA 510(k) clearance for MODIFICATION TO: ROEI WORKING ELEMENT A..., manufactured by Roei Medical Technologies, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FAS cleared through the Special 510(k) pathway after a 37-day FDA review.

K053322 · Roei Medical Technologies, Ltd. · Gastroenterology & Urology device
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Jan 2006
Decision
37d
Days
Class 2
Risk

K053322 is an FDA 510(k) clearance for the MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS. Classified as Electrode, Electrosurgical, Active, Urological (product code FAS), Class II - Special Controls.

Submitted by Roei Medical Technologies, Ltd. (Washington, US). The FDA issued a Cleared decision on January 6, 2006 after a review of 37 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 Roei Medical Technologies, Ltd. devices

FDA 510(k) Submission Details - K053322

510(k) Number K053322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2005
Decision Date January 06, 2006
Days to Decision 37 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
93d faster than avg
Panel avg: 130d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

FAS Device Classification - Class 2, Special Controls

Product Code FAS Electrode, Electrosurgical, Active, Urological
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 - FAS Electrode, Electrosurgical, Active, Urological

All 29
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