K170210 is an FDA 510(k) clearance for the PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0. This device is classified as a System, Imaging, Gastrointestinal, Wireless, Capsule (Class II - Special Controls, product code NEZ).
Submitted by Given Imaging , Ltd. (Yoqneam, IL). The FDA issued a Cleared decision on September 1, 2017, 220 days after receiving the submission on January 24, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1300.
| 510(k) Number | K170210 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2017 |
| Decision Date | September 01, 2017 |
| Days to Decision | 220 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 |