GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM— 510(k) K090557

Substantially Equivalent

Given Imaging , Ltd.

FDA 510(k) clearance K090557 for GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM, Substantially Equivalent on 2009-09-28. Applicant: Given Imaging , Ltd.. Device class: 2.

Clearance details

Applicant
Given Imaging , Ltd.
Product code
Code NSI
Device class
Class 2
Regulation
21 CFR 876.1300
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Yoqneaam, IL
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