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FDA 510(k)

Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)

K-Number: K252279 · 2026-04-17

ApplicantChirana T.Injecta,A.S.
Decision Date2026-04-17
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) is the device name listed in this FDA 510(k) record. The listed applicant is Chirana T.Injecta,A.S.. It received FDA 510(k) clearance on 2026-04-17 under 510(k) number K252279. 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 Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)?

Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) is a medical device that received FDA 510(k) clearance on 2026-04-17. The listed applicant is Chirana T.Injecta,A.S.. The 510(k) number is K252279.

When did Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) receive FDA 510(k) clearance?

Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) received FDA 510(k) clearance on 2026-04-17, under 510(k) number K252279.

Who is the listed applicant for Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)?

The FDA 510(k) record lists Chirana T.Injecta,A.S. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)?

The FDA product code for Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) 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.

NCT06411054The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVARECRUITING

Other records listing Chirana T.Injecta,A.S. 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.

K252483Enteral Syringe (20ml, 60ml)

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.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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