Cleared Traditional

K053639 - GIVEN DIAGNOSTIC SYSTEM

K053639 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 129-day FDA review.

K053639 · Given Imaging , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
129d
Days
Class 2
Risk

K053639 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. (Yoqneaam, IL). The FDA issued a Cleared decision on May 8, 2006 after a review of 129 days - within the typical 510(k) review window.

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 - K053639

510(k) Number K053639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2005
Decision Date May 08, 2006
Days to Decision 129 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
1d faster than avg
Panel avg: 130d · This submission: 129d
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 K053639.
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
K063259 · Olympus Medical Systems Corporation · Sep 2007
MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM
K070475 · Given Imaging , Ltd. · May 2007
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
K062786 · Given Imaging , Ltd. · Oct 2006
CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143
K040494 · United States Endoscopy Group, Inc. · Jun 2004
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
K040248 · Given Imaging , Ltd. · Feb 2004
GIVEN DIAGNOSTIC SYSTEM
K032405 · Given Imaging , Ltd. · Oct 2003