Cleared Traditional

K180171 - PillCam Patency System (FDA 510(k) Clearance)

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

K180171 · Given Imaging , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
45d
Days
Class 2
Risk

K180171 is an FDA 510(k) clearance for the PillCam Patency System. Classified as System, Imaging, Esophageal, Wireless, Capsule (product code NSI), Class II - Special Controls.

Submitted by Given Imaging , Ltd. (Yoqneam, IL). The FDA issued a Cleared decision on March 8, 2018 after a review of 45 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Given Imaging , Ltd. devices

Submission Details

510(k) Number K180171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2018
Decision Date March 08, 2018
Days to Decision 45 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
85d faster than avg
Panel avg: 130d · This submission: 45d
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.