510(k) K153466

Device: PillCam COLON 2 Capsule Endoscopy System
Applicant: GIVEN IMAGING LTD.
510(k) number: K153466
Product code: PGD
Decision: Substantially Equivalent (SESE)
Decision date: 2016-01-14
Date received: 2015-12-01
Regulation: 876.1330
Classification name: Colon Capsule Imaging System
Medical specialty: Gastroenterology/Urology
Review panel: Gastroenterology/Urology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: HILLA DEBBY
Address: 2 Hacarmel St. New Industrial Park Pob 258 Yoqneam IL 20962 20962

FDA Registration Numbers#

9710107
3018094310

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
07290101364825	PillCam	Given Imaging, Inc.	2017-02-01
07290101364801	PillCam	Given Imaging, Inc.	2017-02-01
07290101364795	PillCam	Given Imaging, Inc.	2017-02-01
07290101364832	PillCam	Given Imaging, Inc.	2017-01-31
07290101364818	PillCam	Given Imaging, Inc.	2017-01-31
07290101364788	PillCam	Given Imaging, Inc.	2017-01-31

Other 510(k) Records For Product Code PGD #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
DEN120023	GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM	Given Imaging , Ltd.	2014-01-29

Legacy Summary#

summary

FDA Review#

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