Cleared Special

K040248 - MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

K040248 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 14-day FDA review.

K040248 · Given Imaging , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
14d
Days
Class 2
Risk

K040248 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, IL). The FDA issued a Cleared decision on February 17, 2004 after a review of 14 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 - K040248

510(k) Number K040248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2004
Decision Date February 17, 2004
Days to Decision 14 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
116d faster than avg
Panel avg: 130d · This submission: 14d
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 K040248.
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K040494 · United States Endoscopy Group, Inc. · Jun 2004
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K031033 · Given Imaging , Ltd. · Jul 2003
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
K022980 · Given Imaging , Ltd. · Feb 2003