K042960 is an FDA 510(k) clearance for the GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO. This device is classified as a System, Imaging, Esophageal, Wireless, Capsule (Class II - Special Controls, product code NSI).
Submitted by Given Imaging , Ltd. (Yokneam, IL). The FDA issued a Cleared decision on November 24, 2004, 28 days after receiving the submission on October 27, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1300. The Capsule Is A Disposable, Ingestible Capsule Designed To Acquire Video Images Of The Esophagus. The Capsule Transmits The Acquired Images Via Rf Communication Channel To A Data Recorder Located Outside The Body. The Diagnostic Imaging System Is Intended For Visualization Of The Esophagus Rather Than The Small Bowel..
| 510(k) Number | K042960 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 2004 |
| Decision Date | November 24, 2004 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NSI — System, Imaging, Esophageal, Wireless, Capsule |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1300 |
| Definition | The Capsule Is A Disposable, Ingestible Capsule Designed To Acquire Video Images Of The Esophagus. The Capsule Transmits The Acquired Images Via Rf Communication Channel To A Data Recorder Located Outside The Body. The Diagnostic Imaging System Is Intended For Visualization Of The Esophagus Rather Than The Small Bowel. |