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FDA 510(k)

EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)

K-Number: K241209 · 2024-07-29

ApplicantCook Ireland, Ltd.
Decision Date2024-07-29
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) is a medical device manufactured by Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2024-07-29 under approval number K241209. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)?

EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) is a medical device that received FDA 510(k) clearance on 2024-07-29. It is manufactured by Cook Ireland, Ltd.. The 510(k) number is K241209.

When was EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) approved by the FDA?

EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) received FDA 510(k) clearance on 2024-07-29, under approval number K241209.

What company makes EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)?

EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) is manufactured by Cook Ireland, Ltd..

What is the FDA product code for EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)?

The FDA product code for EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) is FCG.

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Related Devices (Code: FCG)

K160423Perineologic Access NeedleCorbin Clinical Resources, LLC K160098Single Use Aspiration Needle NA-U401SXOlympus Medical Systems Corp. K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy NeedleCook Ireland, Ltd. K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd. K171596ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound NeedleWilson-Cook Medical, Inc. K160890Howell Biliary Introducer NeedleWilson-Cook Medical, Inc.

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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