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FDA 510(k)

Sofjec

K-Number: K212635 · 2023-02-13

ApplicantHwajin Medical Co., Ltd.
Decision Date2023-02-13
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sofjec is the device name listed in this FDA 510(k) record. The listed applicant is Hwajin Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-02-13 under 510(k) number K212635. 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 Sofjec?

Sofjec is a medical device that received FDA 510(k) clearance on 2023-02-13. The listed applicant is Hwajin Medical Co., Ltd.. The 510(k) number is K212635.

When did Sofjec receive FDA 510(k) clearance?

Sofjec received FDA 510(k) clearance on 2023-02-13, under 510(k) number K212635.

Who is the listed applicant for Sofjec?

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

What is the FDA product code for Sofjec?

The FDA product code for Sofjec is FMF.

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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