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FDA 510(k)

1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock

K-Number: K210200 · 2021-05-14

ApplicantSet Medikal Sanayi VE Ticaret Anonim Sirketi
Decision Date2021-05-14
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock is a medical device manufactured by Set Medikal Sanayi VE Ticaret Anonim Sirketi. It received FDA 510(k) clearance on 2021-05-14 under approval number K210200. 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 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock?

1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock is a medical device that received FDA 510(k) clearance on 2021-05-14. It is manufactured by Set Medikal Sanayi VE Ticaret Anonim Sirketi. The 510(k) number is K210200.

When was 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock approved by the FDA?

1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock received FDA 510(k) clearance on 2021-05-14, under approval number K210200.

What company makes 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock?

1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock is manufactured by Set Medikal Sanayi VE Ticaret Anonim Sirketi.

What is the FDA product code for 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock?

The FDA product code for 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock 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)

Other Devices by Set Medikal Sanayi VE Ticaret Anonim Sirketi

K201284Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use

Related Devices (Code: FMF)

K162180Disposable Insulin SyringeBerpu Medical Technology Co., Ltd. K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin SyringeBecton, Dickinson and Company K162602NovoPen EchoNovo Nordisk, Inc. K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. K152879Sure-Fine Insulin SyringesShina Med Corporation K160629InPenCompanion Medical, Inc.

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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