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FDA 510(k)

Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter

K-Number: K231918 · 2023-11-03

ApplicantKoru Medical Systems
Decision Date2023-11-03
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter is a medical device manufactured by Koru Medical Systems. It received FDA 510(k) clearance on 2023-11-03 under approval number K231918. 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 Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter?

Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter is a medical device that received FDA 510(k) clearance on 2023-11-03. It is manufactured by Koru Medical Systems. The 510(k) number is K231918.

When was Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter approved by the FDA?

Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter received FDA 510(k) clearance on 2023-11-03, under approval number K231918.

What company makes Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter?

Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter is manufactured by Koru Medical Systems.

What is the FDA product code for Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter?

The FDA product code for Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter is FRN.

Related Clinical Trials

NCT07607249 Clinical Study on the Treatment of Gastrointestinal Dysfunction After Knee Joint Surgery Under General Anesthesia With Floating Needle ENROLLING_BY_INVITATION 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 NCT07548892 Comparison of Needle-Free Injection and Conventional Syringe for Tooth Extractions in Children NOT_YET_RECRUITING NCT06281249 Neuraxial Ultrasound Device Study NOT_YET_RECRUITING NCT02812927 Evaluation of Glycemic Variability (GLAIVE) COMPLETED NCT06918587 A Comparative Evaluation of Pharmacokinetics and Immunogenicity. COMPLETED

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

View on FDA Database →

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

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