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

Name: FDA 510(k) clearance K153466
Creator: U.S. Food and Drug Administration
Published: 2016-01-14

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.. Device class: 2.

Clearance details

Applicant: Given Imaging , Ltd.
Product code: Code PGD
Device class: Class 2
Regulation: 21 CFR 876.1330
Advisory panel: Gastroenterology, Urology
Date received: 2015-12-01
Decision date: 2016-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yoqneam, IL

Download summary PDF View on FDA.gov ↗

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