K153466 is an FDA 510(k) clearance for the PillCam COLON 2 Capsule Endoscopy System. This device is classified as a Colon Capsule Imaging System (Class II - Special Controls, product code PGD).
Submitted by Given Imaging , Ltd. (Yoqneam, IL). The FDA issued a Cleared decision on January 14, 2016, 44 days after receiving the submission on December 1, 2015.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1330. Visualization Of The Colon For The Detection Of Polyps.
| 510(k) Number | K153466 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 2015 |
| Decision Date | January 14, 2016 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PGD — Colon Capsule Imaging System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1330 |
| Definition | Visualization Of The Colon For The Detection Of Polyps |