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FDA 510(k)

Disposable Pen Injector (KXYC-03C02, KXYC-03A03)

K-Number: K253747 · 2026-08-14

ApplicantJiangsu Enjosim Medical Technology Co., Ltd.
Decision Date2026-08-14
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Pen Injector (KXYC-03C02, KXYC-03A03) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Enjosim Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-08-14 under 510(k) number K253747. 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 Disposable Pen Injector (KXYC-03C02, KXYC-03A03)?

Disposable Pen Injector (KXYC-03C02, KXYC-03A03) is a medical device that received FDA 510(k) clearance on 2026-08-14. The listed applicant is Jiangsu Enjosim Medical Technology Co., Ltd.. The 510(k) number is K253747.

When did Disposable Pen Injector (KXYC-03C02, KXYC-03A03) receive FDA 510(k) clearance?

Disposable Pen Injector (KXYC-03C02, KXYC-03A03) received FDA 510(k) clearance on 2026-08-14, under 510(k) number K253747.

Who is the listed applicant for Disposable Pen Injector (KXYC-03C02, KXYC-03A03)?

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

What is the FDA product code for Disposable Pen Injector (KXYC-03C02, KXYC-03A03)?

The FDA product code for Disposable Pen Injector (KXYC-03C02, KXYC-03A03) 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.

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.K253068Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin SyringeCMT Health PTE., Ltd.

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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