Cleared Traditional

K032405 - GIVEN DIAGNOSTIC SYSTEM

K032405 is an FDA 510(k) clearance for 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 86-day FDA review.

K032405 · Given Imaging , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
86d
Days
Class 2
Risk

K032405 is an FDA 510(k) clearance for the 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 October 29, 2003 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Given Imaging , Ltd. devices

FDA 510(k) Submission Details - K032405

510(k) Number K032405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2003
Decision Date October 29, 2003
Days to Decision 86 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
44d faster than avg
Panel avg: 130d · This submission: 86d
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 39
Devices cleared under the same product code (NEZ) and FDA review panel - the closest regulatory comparables to K032405.
GIVEN DIAGNOSTIC SYSTEM
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K040248 · Given Imaging , Ltd. · Feb 2004
GIVEN DIAGNOSTIC SYSTEM
K031033 · Given Imaging , Ltd. · Jul 2003
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
K022980 · Given Imaging , Ltd. · Feb 2003
GIVEN DIAGNOSTICS SYSTEM
K022362 · Given Imaging , Ltd. · Aug 2002