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FDA 510(k)

Orbit Inserter

K-Number: K163400 · 2017-07-26

ApplicantYpsomed AG
Decision Date2017-07-26
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Orbit Inserter is a medical device manufactured by Ypsomed AG. It received FDA 510(k) clearance on 2017-07-26 under approval number K163400. The device is classified under product code KZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Orbit Inserter?

Orbit Inserter is a medical device that received FDA 510(k) clearance on 2017-07-26. It is manufactured by Ypsomed AG. The 510(k) number is K163400.

When was Orbit Inserter approved by the FDA?

Orbit Inserter received FDA 510(k) clearance on 2017-07-26, under approval number K163400.

What company makes Orbit Inserter?

Orbit Inserter is manufactured by Ypsomed AG.

What is the FDA product code for Orbit Inserter?

The FDA product code for Orbit Inserter is KZH.

Other Devices by Ypsomed AG

K150921Orbit Infusion Set K171984Clickfine Pen Needle, Penfine Classic Pen Needle K243901SmartPilot YpsoMate NS-A2.25

Related Devices (Code: KZH)

K160860MiniMed Quick-serterMedtronic Minimed K213429AccuSert Needle InserterEmed Technologies Corporation K243232GripMateSynthon Hispania S.L.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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