Cleared Special

K042960 - GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO

K042960 is an FDA 510(k) clearance for GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO, manufactured by Given Imaging , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code NSI cleared through the Special 510(k) pathway after a 28-day FDA review.

K042960 · Given Imaging , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
28d
Days
Class 2
Risk

K042960 is an FDA 510(k) clearance for the GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO. Classified as System, Imaging, Esophageal, Wireless, Capsule (product code NSI), Class II - Special Controls.

Submitted by Given Imaging , Ltd. (Yokneam, IL). The FDA issued a Cleared decision on November 24, 2004 after a review of 28 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

FDA 510(k) Submission Details - K042960

510(k) Number K042960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2004
Decision Date November 24, 2004
Days to Decision 28 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
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

NSI Device Classification - Class 2, Special Controls

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.

Regulatory Peers - NSI System, Imaging, Esophageal, Wireless, Capsule

Devices cleared under the same product code (NSI) and FDA review panel - the closest regulatory comparables to K042960.
GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE
K071153 · Given Imaging , Ltd. · Jun 2007
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
K060805 · Given Imaging , Ltd. · May 2006
GIVEN DIAGNOSTIC SYSTEM
K052184 · Given Imaging , Ltd. · Dec 2005
GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE
K041149 · Given Imaging , Ltd. · Oct 2004