Orbit Inserter— 510(k) K163400

Substantially Equivalent

Ypsomed AG

FDA 510(k) clearance K163400 for Orbit Inserter, Substantially Equivalent on 2017-07-26. Applicant: Ypsomed AG.

Clearance details

Applicant: Ypsomed AG
Product code: Code KZH
Advisory panel: General Hospital
Date received: 2016-12-05
Decision date: 2017-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burgdorf, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code KZH

product code KZH

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.