Cleared Traditional

GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM (K090557) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K090557 · Given Imaging , Ltd. · Gastroenterology & Urology device
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Sep 2009
Decision
210d
Days
Class 2
Risk

K090557 is an FDA 510(k) clearance for the GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PA.... Classified as System, Imaging, Esophageal, Wireless, Capsule (product code NSI), Class II - Special Controls.

Submitted by Given Imaging , Ltd. (Yoqneaam, IL). The FDA issued a Cleared decision on September 28, 2009 after a review of 210 days - an extended review 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: 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.

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Submission Details

510(k) Number K090557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2009
Decision Date September 28, 2009
Days to Decision 210 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 130d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.