Cleared Special

K091405 - PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT

K091405 is an FDA 510(k) clearance for PILLCAM PLATFORM WITH PILLCAM SB CAPSUL..., 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 78-day FDA review.

K091405 · Given Imaging , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
78d
Days
Class 2
Risk

K091405 is an FDA 510(k) clearance for the PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT. 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 July 29, 2009 after a review of 78 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.

FDA 510(k) Submission Details - K091405

510(k) Number K091405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2009
Decision Date July 29, 2009
Days to Decision 78 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
53d faster than avg
Panel avg: 131d · This submission: 78d
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 46
Devices cleared under the same product code (NEZ) and FDA review panel - the closest regulatory comparables to K091405.
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT
K103088 · Given Imaging , Ltd. · Jan 2011
PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE
K101200 · Given Imaging , Ltd. · Sep 2010
MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM
K090210 · Olympus Medical Systems Corporation · Jul 2009
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
K091405 · PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT
Download PDF FDA Summary Given Imaging , Ltd.