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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 a medical device manufactured by Chirana T.Injecta,A.S.. It received FDA 510(k) clearance on 2026-04-17 under approval 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. It is manufactured by Chirana T.Injecta,A.S.. The 510(k) number is K252279.

When was Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) approved by the FDA?

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

What company makes Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)?

Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) is manufactured by Chirana T.Injecta,A.S..

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

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Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Related Devices (Code: FMF)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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