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FDA 510(k)

FreedomEdge(R) Syringe Infusion System

K-Number: K211206 · 2021-11-09

ApplicantRepro-Medical System, Inc., Dba Koru Medical Systems
Decision Date2021-11-09
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FreedomEdge(R) Syringe Infusion System is a medical device manufactured by Repro-Medical System, Inc., Dba Koru Medical Systems. It received FDA 510(k) clearance on 2021-11-09 under approval number K211206. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FreedomEdge(R) Syringe Infusion System?

FreedomEdge(R) Syringe Infusion System is a medical device that received FDA 510(k) clearance on 2021-11-09. It is manufactured by Repro-Medical System, Inc., Dba Koru Medical Systems. The 510(k) number is K211206.

When was FreedomEdge(R) Syringe Infusion System approved by the FDA?

FreedomEdge(R) Syringe Infusion System received FDA 510(k) clearance on 2021-11-09, under approval number K211206.

What company makes FreedomEdge(R) Syringe Infusion System?

FreedomEdge(R) Syringe Infusion System is manufactured by Repro-Medical System, Inc., Dba Koru Medical Systems.

What is the FDA product code for FreedomEdge(R) Syringe Infusion System?

The FDA product code for FreedomEdge(R) Syringe Infusion System is FRN.

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 NCT07581249 This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary Teeth COMPLETED NCT06411054 The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVA 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 NCT07548892 Comparison of Needle-Free Injection and Conventional Syringe for Tooth Extractions in Children NOT_YET_RECRUITING

Other Devices by Repro-Medical System, Inc., Dba Koru Medical Systems

K214045FreedomEdge Syringe Infusion System

Related Devices (Code: FRN)

K143369MRidium 3860+ MRI infusion Pump/ Monitoring SystemIradimed Corporation K153599Concert Medical Hands-Free Syringe (HFS)Concert Medical, LLC K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)Zyno Medical, LLC K162613Integrated Catch-up Freedom Syringe Driver Infusion SystemRepro-Med Systems, Inc. Dba Rms Medical Products K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. K161667Sapphire Infusion PumpQ Core Medical , Ltd.

Official Source

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

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