Cleared Special

GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE (K071153) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K071153 · Given Imaging , Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jun 2007
Decision
47d
Days
Class 2
Risk

K071153 is an FDA 510(k) clearance for the GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE. Classified as System, Imaging, Esophageal, Wireless, Capsule (product code NSI), Class II - Special Controls.

Submitted by Given Imaging , Ltd. (Calgary, Alberta, CA). The FDA issued a Cleared decision on June 11, 2007 after a review of 47 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

Submission Details

510(k) Number K071153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2007
Decision Date June 11, 2007
Days to Decision 47 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 130d · This submission: 47d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NSI System, Imaging, Esophageal, Wireless, Capsule
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1300
Definition The Capsule Is A Disposable, Ingestible Capsule Designed To Acquire Video Images Of The Esophagus. The Capsule Transmits The Acquired Images Via Rf Communication Channel To A Data Recorder Located Outside The Body. The Diagnostic Imaging System Is Intended For Visualization Of The Esophagus Rather Than The Small Bowel.
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.