Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Piper Access, LLC. It received FDA 510(k) clearance on 2019-11-13 under approval 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. It is manufactured by Piper Access, LLC. The 510(k) number is K191976.

When was Piper GO-IO Intraosseous Infusion System approved by the FDA?

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

What company makes Piper GO-IO Intraosseous Infusion System?

Piper GO-IO Intraosseous Infusion System is manufactured by Piper Access, LLC.

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.

Related Clinical Trials

NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT07575191 Safety and Performance of a Novel Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Pancreatic Cancer NOT_YET_RECRUITING NCT05286814 PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma RECRUITING NCT07510451 The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery RECRUITING NCT02812927 Evaluation of Glycemic Variability (GLAIVE) COMPLETED NCT01866514 Proximal Humerus Site for Anesthesia COMPLETED

Other Devices by Piper Access, LLC

K1819045 FR Dual Lumen Piper PICC K210047Stiletto Extended Dwell Catheter

Related Devices (Code: FMI)

K162516BD Pen NeedleBecton, Dickinson and Company K160532Greiner HoldexGreiner Bio-One Na, Inc. K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc. K151090CPL Insulin Pen NeedleCpl Co., Ltd. K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc. K153706Insulin Pen NeedleSteriLance Medical (Suzhou), Inc.

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.

↑