Cleared Traditional

Piper GO-IO Intraosseous Infusion System

K191976 · Piper Access, LLC · General Hospital

Nov 2019

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K191976 is an FDA 510(k) clearance for the Piper GO-IO Intraosseous Infusion System, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Piper Access, LLC (Salt Lake City, US). The FDA issued a Cleared decision on November 13, 2019, 112 days after receiving the submission on July 24, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K191976 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 24, 2019
Decision Date	November 13, 2019
Days to Decision	112 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF