Cleared Special

K070475 - MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM

K070475 is an FDA 510(k) clearance for MODIFICATON TO: GIVEN DIAGNOSTIC IMAGIN..., 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 76-day FDA review.

K070475 · Given Imaging , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
76d
Days
Class 2
Risk

K070475 is an FDA 510(k) clearance for the MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM. Classified as System, Imaging, Gastrointestinal, Wireless, Capsule (product code NEZ), Class II - Special Controls.

Submitted by Given Imaging , Ltd. (Calgary, Alberta, CA). The FDA issued a Cleared decision on May 7, 2007 after a review of 76 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.

FDA 510(k) Submission Details - K070475

510(k) Number K070475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2007
Decision Date May 07, 2007
Days to Decision 76 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
55d faster than avg
Panel avg: 131d · This submission: 76d
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 46
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K070475 · MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM
Download PDF FDA Summary Given Imaging , Ltd.