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FDA 510(k)

Closed System Transfer Device

K-Number: K201460 · 2022-11-23

ApplicantShinva Ande Healthcare Apparatus Co., Ltd.
Decision Date2022-11-23
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Closed System Transfer Device is a medical device manufactured by Shinva Ande Healthcare Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2022-11-23 under approval number K201460. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Closed System Transfer Device?

Closed System Transfer Device is a medical device that received FDA 510(k) clearance on 2022-11-23. It is manufactured by Shinva Ande Healthcare Apparatus Co., Ltd.. The 510(k) number is K201460.

When was Closed System Transfer Device approved by the FDA?

Closed System Transfer Device received FDA 510(k) clearance on 2022-11-23, under approval number K201460.

What company makes Closed System Transfer Device?

Closed System Transfer Device is manufactured by Shinva Ande Healthcare Apparatus Co., Ltd..

What is the FDA product code for Closed System Transfer Device?

The FDA product code for Closed System Transfer Device is ONB.

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Shinva Ande Healthcare Apparatus Co., Ltd.

K162601Infusion Set for Single Use K193657Disposable Enteral Feeding Syringe with Enfit Connector K202060Disposable IV catheter K220057Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization K211484Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles

Related Devices (Code: ONB)

K170706Equashield Closed System drug Transfer Device (CSTD)Equashield Medical , Ltd. K170680TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant K181221BD PhaSeal Optima Closed System Transfer DeviceBecton, Dickinson and Company K180489TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant K173477ChemoCLAVE Cytotoxic Medication Preparation and Delivery SystemIcu Medical, Inc. K180574Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial AdaptorJ & J Solutions, Inc. D/B/A/ Corvida Medical

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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