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FDA 510(k)

PillCam COLON 2 Capsule Endoscopy System

K-Number: K153466 · 2016-01-14

ApplicantGiven Imaging , Ltd.
Decision Date2016-01-14
Product CodePGD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PillCam COLON 2 Capsule Endoscopy System is a medical device manufactured by Given Imaging , Ltd.. It received FDA 510(k) clearance on 2016-01-14 under approval number K153466. The device is classified under product code PGD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PillCam COLON 2 Capsule Endoscopy System?

PillCam COLON 2 Capsule Endoscopy System is a medical device that received FDA 510(k) clearance on 2016-01-14. It is manufactured by Given Imaging , Ltd.. The 510(k) number is K153466.

When was PillCam COLON 2 Capsule Endoscopy System approved by the FDA?

PillCam COLON 2 Capsule Endoscopy System received FDA 510(k) clearance on 2016-01-14, under approval number K153466.

What company makes PillCam COLON 2 Capsule Endoscopy System?

PillCam COLON 2 Capsule Endoscopy System is manufactured by Given Imaging , Ltd..

What is the FDA product code for PillCam COLON 2 Capsule Endoscopy System?

The FDA product code for PillCam COLON 2 Capsule Endoscopy System is PGD.

Related Clinical Trials

NCT07027826 The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States RECRUITING NCT00702533 A New Method for Determining Gastric Acid Output Using a Wireless Capsule COMPLETED NCT04605302 Comparative Study of MCCE With/Without Tether vs Conventional Upper Endoscopy in Patients With Upper Abdominal Symptoms COMPLETED NCT07587437 Preoperative Use of a Magnetically Controlled Capsule Endoscopy in Patients Undergoing Bariatric Surgery ENROLLING_BY_INVITATION NCT07089615 Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference RECRUITING NCT05822895 Review of the Impact of a Computer-aided Real-time Polyp Detection System on Adult Colonoscopy RECRUITING

Other Devices by Given Imaging , Ltd.

K151086ManoScan System K170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 K170839RAPID Web K180171PillCam Patency System

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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