K040494 is an FDA 510(k) clearance for the CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143. This device is classified as a System, Imaging, Gastrointestinal, Wireless, Capsule (Class II - Special Controls, product code NEZ).
Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on June 23, 2004, 118 days after receiving the submission on February 26, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1300.
| 510(k) Number | K040494 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2004 |
| Decision Date | June 23, 2004 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | NEZ - System, Imaging, Gastrointestinal, Wireless, Capsule |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1300 |