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FDA 510(k)

Piper GO-IO Intraosseous Infusion System

K-Number: K191976 · 2019-11-13

ApplicantPiper Access, LLC
Decision Date2019-11-13
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Piper GO-IO Intraosseous Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Piper Access, LLC. It received FDA 510(k) clearance on 2019-11-13 under 510(k) number K191976. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Piper GO-IO Intraosseous Infusion System?

Piper GO-IO Intraosseous Infusion System is a medical device that received FDA 510(k) clearance on 2019-11-13. The listed applicant is Piper Access, LLC. The 510(k) number is K191976.

When did Piper GO-IO Intraosseous Infusion System receive FDA 510(k) clearance?

Piper GO-IO Intraosseous Infusion System received FDA 510(k) clearance on 2019-11-13, under 510(k) number K191976.

Who is the listed applicant for Piper GO-IO Intraosseous Infusion System?

The FDA 510(k) record lists Piper Access, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Piper GO-IO Intraosseous Infusion System?

The FDA product code for Piper GO-IO Intraosseous Infusion System is FMI.

Other records listing Piper Access, LLC as applicant

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Official Source

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