Not Cleared Post-NSE

DEN010002 - GIVEN DIAGNOSTIC IMAGING SYSTEM (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN010002 · Given Imaging , Ltd. · Gastroenterology & Urology device
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Aug 2001
Decision
51d
Days
Class 2
Risk

DEN010002 is an FDA 510(k) submission (not cleared) for the GIVEN DIAGNOSTIC IMAGING SYSTEM. Classified as System, Imaging, Gastrointestinal, Wireless, Capsule (product code NEZ), Class II - Special Controls.

Submitted by Given Imaging , Ltd. (Ra'Ananna 43373, IL). The FDA issued a Not Cleared (DENG) decision on August 1, 2001 after a review of 51 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1300 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Gastroenterology & Urology review framework.

View all Given Imaging , Ltd. devices

Submission Details

510(k) Number DEN010002 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 11, 2001
Decision Date August 01, 2001
Days to Decision 51 days
Submission Type Post-NSE
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 130d · This submission: 51d
Pathway characteristics

Device Classification

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 45
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