FDA 510(k)

Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe

K-Number: K213013 · 2022-09-19

Decision Date2022-09-19

Product CodeQNQ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe is a medical device manufactured by Jeil Tech Co., Ltd.. It received FDA 510(k) clearance on 2022-09-19 under approval number K213013. The device is classified under product code QNQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe?

Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe is a medical device that received FDA 510(k) clearance on 2022-09-19. It is manufactured by Jeil Tech Co., Ltd.. The 510(k) number is K213013.

When was Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe approved by the FDA?

Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe received FDA 510(k) clearance on 2022-09-19, under approval number K213013.

What company makes Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe?

Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe is manufactured by Jeil Tech Co., Ltd..

What is the FDA product code for Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe?

The FDA product code for Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe is QNQ.

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Related PubMed Literature

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Related Devices (Code: QNQ)

K210443PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc. K220083LDV((Low Dead Volume )SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. K221860PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile SyringePoonglim Pharmatech, Inc. K213010FEELject LDV (Low dead volume) syringeFeeltech Co., Ltd. K242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable NeedleSol-Millennium Medical, Inc. K232943Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.