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

FDA 510(k)

Concert Medical Hands-Free Syringe (HFS)

K-Number: K153599 · 2016-09-01

ApplicantConcert Medical, LLC
Decision Date2016-09-01
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Concert Medical Hands-Free Syringe (HFS) is the device name listed in this FDA 510(k) record. The listed applicant is Concert Medical, LLC. It received FDA 510(k) clearance on 2016-09-01 under 510(k) number K153599. 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 Concert Medical Hands-Free Syringe (HFS)?

Concert Medical Hands-Free Syringe (HFS) is a medical device that received FDA 510(k) clearance on 2016-09-01. The listed applicant is Concert Medical, LLC. The 510(k) number is K153599.

When did Concert Medical Hands-Free Syringe (HFS) receive FDA 510(k) clearance?

Concert Medical Hands-Free Syringe (HFS) received FDA 510(k) clearance on 2016-09-01, under 510(k) number K153599.

Who is the listed applicant for Concert Medical Hands-Free Syringe (HFS)?

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

What is the FDA product code for Concert Medical Hands-Free Syringe (HFS)?

The FDA product code for Concert Medical Hands-Free Syringe (HFS) is FRN.

Other records listing Concert Medical, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K153397S-Wire Guidewire System

Related Devices (Code: FRN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, 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.

↑