FDA 510(k)

Orbit Inserter

K-Number: K163400 · 2017-07-26

Decision Date2017-07-26

Product CodeKZH

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Orbit Inserter is the device name listed in this FDA 510(k) record. The listed applicant is Ypsomed AG. It received FDA 510(k) clearance on 2017-07-26 under 510(k) 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. The listed applicant is Ypsomed AG. The 510(k) number is K163400.

When did Orbit Inserter receive FDA 510(k) clearance?

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

Who is the listed applicant for Orbit Inserter?

The FDA 510(k) record lists Ypsomed AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Orbit Inserter?

The FDA product code for Orbit Inserter is KZH.

Other records listing Ypsomed AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: KZH)

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

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.