Cleared Special

K062786 - MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

K062786 is an FDA 510(k) clearance for MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM, manufactured by Given Imaging , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code NEZ cleared through the Special 510(k) pathway after a 30-day FDA review.

K062786 · Given Imaging , Ltd. · Gastroenterology & Urology device
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Oct 2006
Decision
30d
Days
Class 2
Risk

K062786 is an FDA 510(k) clearance for the MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM. Classified as System, Imaging, Gastrointestinal, Wireless, Capsule (product code NEZ), Class II - Special Controls.

Submitted by Given Imaging , Ltd. (Yokneam (P.O.Box 258), IL). The FDA issued a Cleared decision on October 18, 2006 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1300 - 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 Given Imaging , Ltd. devices

FDA 510(k) Submission Details - K062786

510(k) Number K062786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2006
Decision Date October 18, 2006
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

NEZ Device Classification - Class 2, Special Controls

Product Code NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1300
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 - NEZ System, Imaging, Gastrointestinal, Wireless, Capsule

All 39
Devices cleared under the same product code (NEZ) and FDA review panel - the closest regulatory comparables to K062786.
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CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143
K040494 · United States Endoscopy Group, Inc. · Jun 2004
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K040248 · Given Imaging , Ltd. · Feb 2004