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FDA 510(k)

Shina Safety Needle

K-Number: K222417 · 2023-03-20

ApplicantShina Corporation
Decision Date2023-03-20
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Shina Safety Needle is a medical device manufactured by Shina Corporation. It received FDA 510(k) clearance on 2023-03-20 under approval number K222417. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Shina Safety Needle?

Shina Safety Needle is a medical device that received FDA 510(k) clearance on 2023-03-20. It is manufactured by Shina Corporation. The 510(k) number is K222417.

When was Shina Safety Needle approved by the FDA?

Shina Safety Needle received FDA 510(k) clearance on 2023-03-20, under approval number K222417.

What company makes Shina Safety Needle?

Shina Safety Needle is manufactured by Shina Corporation.

What is the FDA product code for Shina Safety Needle?

The FDA product code for Shina Safety Needle is FMI.

Related Clinical Trials

NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT06000540 Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects NOT_YET_RECRUITING NCT06204614 Drug Screening Using IMD in Bladder Cancer ENROLLING_BY_INVITATION NCT05231278 Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy COMPLETED NCT04766684 Clubfoot Tenotomy Trial COMPLETED NCT06828250 Intradermal Needle Therapy Relieves Postoperative Pain After Endoscopic Submucosal Dissection (ESD) COMPLETED

Related PubMed Literature

PMID: 30016051 General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device. Final order. Federal register (2018)

Related Devices (Code: FMI)

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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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