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FDA 510(k)

Equashield Closed System Transfer Device

K-Number: K221513 · 2023-02-17

ApplicantEquashield Medical , Ltd.
Decision Date2023-02-17
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Equashield Closed System Transfer Device is a medical device manufactured by Equashield Medical , Ltd.. It received FDA 510(k) clearance on 2023-02-17 under approval number K221513. 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 Equashield Closed System Transfer Device?

Equashield Closed System Transfer Device is a medical device that received FDA 510(k) clearance on 2023-02-17. It is manufactured by Equashield Medical , Ltd.. The 510(k) number is K221513.

When was Equashield Closed System Transfer Device approved by the FDA?

Equashield Closed System Transfer Device received FDA 510(k) clearance on 2023-02-17, under approval number K221513.

What company makes Equashield Closed System Transfer Device?

Equashield Closed System Transfer Device is manufactured by Equashield Medical , Ltd..

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

The FDA product code for Equashield 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 Equashield Medical , Ltd.

K170706Equashield Closed System drug Transfer Device (CSTD)

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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