K163400 is an FDA 510(k) clearance for the Orbit Inserter. This device is classified as a Introducer, Syringe Needle (Class II - Special Controls, product code KZH).
Submitted by Ypsomed AG (Burgdorf, CH). The FDA issued a Cleared decision on July 26, 2017, 233 days after receiving the submission on December 5, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6920.
| 510(k) Number | K163400 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2016 |
| Decision Date | July 26, 2017 |
| Days to Decision | 233 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KZH - Introducer, Syringe Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6920 |