PillCam COLON 2 Capsule Endoscopy System
K-Number: K153466 · 2016-01-14
Device Summary
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. The listed applicant is Given Imaging , Ltd.. The 510(k) number is K153466.
When did PillCam COLON 2 Capsule Endoscopy System receive FDA 510(k) clearance?
PillCam COLON 2 Capsule Endoscopy System received FDA 510(k) clearance on 2016-01-14, under 510(k) number K153466.
Who is the listed applicant for PillCam COLON 2 Capsule Endoscopy System?
The FDA 510(k) record lists Given Imaging , Ltd. as the applicant. This does not by itself establish the device manufacturer.
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.
Other records listing Given Imaging , Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.