K151635 is an FDA 510(k) clearance for the CapsoCam (SV-1). This device is classified as a System, Imaging, Gastrointestinal, Wireless, Capsule (Class II - Special Controls, product code NEZ).
Submitted by CapsoVision, Inc. (Saratoga, US). The FDA issued a Cleared decision on February 9, 2016, 237 days after receiving the submission on June 17, 2015.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1300.
| 510(k) Number | K151635 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2015 |
| Decision Date | February 09, 2016 |
| Days to Decision | 237 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NEZ - System, Imaging, Gastrointestinal, Wireless, Capsule |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1300 |