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FDA 510(k)

Sterile Hypodermic Syringes for Single Use with Needles

K-Number: K221068 · 2022-10-04

ApplicantSichuan Prius Biotechnology Co., Ltd.
Decision Date2022-10-04
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Hypodermic Syringes for Single Use with Needles is a medical device manufactured by Sichuan Prius Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2022-10-04 under approval number K221068. 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 Syringes for Single Use with Needles?

Sterile Hypodermic Syringes for Single Use with Needles is a medical device that received FDA 510(k) clearance on 2022-10-04. It is manufactured by Sichuan Prius Biotechnology Co., Ltd.. The 510(k) number is K221068.

When was Sterile Hypodermic Syringes for Single Use with Needles approved by the FDA?

Sterile Hypodermic Syringes for Single Use with Needles received FDA 510(k) clearance on 2022-10-04, under approval number K221068.

What company makes Sterile Hypodermic Syringes for Single Use with Needles?

Sterile Hypodermic Syringes for Single Use with Needles is manufactured by Sichuan Prius Biotechnology Co., Ltd..

What is the FDA product code for Sterile Hypodermic Syringes for Single Use with Needles?

The FDA product code for Sterile Hypodermic Syringes for Single Use with Needles is FMF.

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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 Sichuan Prius Biotechnology Co., Ltd.

K210908Surgical Mask K221078Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use K221075Infusion Sets for Single Use K221069Infusion Sets for Single Use with Needles K221079Sterile Hypodermic Syringes for Single Use K221080Sterile Safety Hypodermic Needles for Single Use

View all 9 devices →

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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