PillCam COLON 2 Capsule Endoscopy System— 510(k) K153466

Substantially Equivalent

Given Imaging , Ltd.

FDA 510(k) clearance K153466 for PillCam COLON 2 Capsule Endoscopy System, Substantially Equivalent on 2016-01-14. Applicant: Given Imaging , Ltd..

Clearance details

Applicant: Given Imaging , Ltd.
Product code: Code PGD
Advisory panel: Gastroenterology, Urology
Date received: 2015-12-01
Decision date: 2016-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yoqneam, IL

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