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FDA 510(k)

Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder

K-Number: K163073 · 2017-05-19

ApplicantSol-Millennium Medical, Inc.
Decision Date2017-05-19
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder is a medical device manufactured by Sol-Millennium Medical, Inc.. It received FDA 510(k) clearance on 2017-05-19 under approval number K163073. 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 Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder?

Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder is a medical device that received FDA 510(k) clearance on 2017-05-19. It is manufactured by Sol-Millennium Medical, Inc.. The 510(k) number is K163073.

When was Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder approved by the FDA?

Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder received FDA 510(k) clearance on 2017-05-19, under approval number K163073.

What company makes Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder?

Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder is manufactured by Sol-Millennium Medical, Inc..

What is the FDA product code for Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder?

The FDA product code for Sol-Care Safety Blood Collection Needle with and without Pre-Attached 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 Sol-Millennium Medical, Inc.

K1620300.5ml Sol-Care Retractable Safety Syringe with Fixed Needle K153537Sol-M Insulin Syringe, Sol-M TB Syringe K182146Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set K222744Sol-M Luer Lock Syringe K213718SOL-GUARD Safety Pull Button Collection Set K220713Sol-Guard Auto-disable Syringe

View all 11 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 K163508PIVOVelano Vascular K172763Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with HolderZhejiang Kindly Medical Devices Co., Ltd.

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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