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FDA 510(k)

Medafor Direct Gas-Assisted Application System

K-Number: K123325 · 2013-01-24

ApplicantMedafor, Inc.
Decision Date2013-01-24
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Medafor Direct Gas-Assisted Application System is the device name listed in this FDA 510(k) record. The listed applicant is Medafor, Inc.. It received FDA 510(k) clearance on 2013-01-24 under 510(k) number K123325. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medafor Direct Gas-Assisted Application System?

Medafor Direct Gas-Assisted Application System is a medical device that received FDA 510(k) clearance on 2013-01-24. The listed applicant is Medafor, Inc.. The 510(k) number is K123325.

When did Medafor Direct Gas-Assisted Application System receive FDA 510(k) clearance?

Medafor Direct Gas-Assisted Application System received FDA 510(k) clearance on 2013-01-24, under 510(k) number K123325.

Who is the listed applicant for Medafor Direct Gas-Assisted Application System?

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

What is the FDA product code for Medafor Direct Gas-Assisted Application System?

The FDA product code for Medafor Direct Gas-Assisted Application System is GCJ.

Related Clinical Trials

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Other records listing Medafor, Inc. 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.

K033666HEMADERMK021678HEMADERM COTAINING HEMADEX CLOTTING BEADSK013225INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE

Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

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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