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FDA 510(k)

Safety Blood Collection Needles with/without Needle Holder

K-Number: K220900 · 2022-08-10

ApplicantAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Decision Date2022-08-10
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Safety Blood Collection Needles with/without Needle Holder is a medical device manufactured by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2022-08-10 under approval number K220900. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Safety Blood Collection Needles with/without Needle Holder?

Safety Blood Collection Needles with/without Needle Holder is a medical device that received FDA 510(k) clearance on 2022-08-10. It is manufactured by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K220900.

When was Safety Blood Collection Needles with/without Needle Holder approved by the FDA?

Safety Blood Collection Needles with/without Needle Holder received FDA 510(k) clearance on 2022-08-10, under approval number K220900.

What company makes Safety Blood Collection Needles with/without Needle Holder?

Safety Blood Collection Needles with/without Needle Holder is manufactured by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd..

What is the FDA product code for Safety Blood Collection Needles with/without Needle Holder?

The FDA product code for Safety Blood Collection Needles with/without Needle Holder is JKA.

Related Clinical Trials

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Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 42024289 Signal Detection Using Change Point Analysis to Identify Safety Signals from Spontaneous Reports in Aortic Stent Grafts in Japan. Journal of medical systems (2026) 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) PMID: 41322758 Real-World Case Series on Surgi-ORC® in ENT Surgery. Cureus (2025)

Other Devices by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

K190183Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe K211555Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe K202188Safety Blood Collection Sets for Single Use K222124Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle K222141Safety Blood Collection Needle (Without Needle Holder) K220083LDV((Low Dead Volume )Syringe

View all 12 devices →

Related Devices (Code: JKA)

K162233Kurin Blood Culture Collection SetPathway, LLC K160657BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection TubeBecton, Dickinson and Company K153309BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company K152924TIVA¿Velano Vascular K163073Sol-Care Safety Blood Collection Needle with and without Pre-Attached HolderSol-Millennium Medical, Inc. K163508PIVOVelano Vascular

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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