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FDA 510(k)

EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)

K-Number: K182268 · 2019-04-05

ApplicantFlat Medical Co., Ltd.
Decision Date2019-04-05
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) is the device name listed in this FDA 510(k) record. The listed applicant is Flat Medical Co., Ltd.. It received FDA 510(k) clearance on 2019-04-05 under 510(k) number K182268. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)?

EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) is a medical device that received FDA 510(k) clearance on 2019-04-05. The listed applicant is Flat Medical Co., Ltd.. The 510(k) number is K182268.

When did EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) receive FDA 510(k) clearance?

EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) received FDA 510(k) clearance on 2019-04-05, under 510(k) number K182268.

Who is the listed applicant for EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)?

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

What is the FDA product code for EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)?

The FDA product code for EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) is FMF.

Related Clinical Trials

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.

NCT07654907Clinical Evaluation of the EpiFaith™ Syringe in Epidural Pain ManagementNOT_YET_RECRUITING

Other records listing Flat Medical Co., Ltd. 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.

K212615EpiFaith CVK192421EpiFaith Syringe

Related Devices (Code: FMF)

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.

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.

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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