Cleared Traditional

K022980 - MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

K022980 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 Traditional 510(k) pathway after a 171-day FDA review.

K022980 · Given Imaging , Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Feb 2003
Decision
171d
Days
Class 2
Risk

K022980 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. (Yoqneaam, IL). The FDA issued a Cleared decision on February 27, 2003 after a review of 171 days - an extended review cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Given Imaging , Ltd. devices

FDA 510(k) Submission Details - K022980

510(k) Number K022980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2002
Decision Date February 27, 2003
Days to Decision 171 days
Submission Type Traditional
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
40d slower than avg
Panel avg: 131d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
Devices cleared under the same product code (NEZ) and FDA review panel - the closest regulatory comparables to K022980.
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
K040248 · Given Imaging , Ltd. · Feb 2004
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K032405 · Given Imaging , Ltd. · Oct 2003
GIVEN DIAGNOSTIC SYSTEM
K031033 · Given Imaging , Ltd. · Jul 2003
GIVEN DIAGNOSTICS SYSTEM
K022362 · Given Imaging , Ltd. · Aug 2002
GIVEN DIAGNOSTIC SYSTEM
K020341 · Given Imaging , Ltd. · May 2002
GIVEN DIAGNOSTIC IMAGING SYSTEM
DEN010002 · Given Imaging , Ltd. · Aug 2001