The following data is part of a premarket notification filed by Ypsomed Ag with the FDA for Orbit Inserter.
| Device ID | K163400 |
| 510k Number | K163400 |
| Device Name: | Orbit Inserter |
| Classification | Introducer, Syringe Needle |
| Applicant | YPSOMED AG BRUNNMATTSTRASSE 6 Burgdorf, CH Ch-3401 |
| Contact | Stephan Affolter |
| Correspondent | Stephan Affolter YPSOMED AG BRUNNMATTSTRASSE 6 Burgdorf, CH Ch-3401 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-05 |
| Decision Date | 2017-07-26 |
| Summary: | summary |