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FDA 510(k)

EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)

K-Number: K230909 · 2023-05-30

ApplicantCook Ireland, Ltd.
Decision Date2023-05-30
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) is a medical device manufactured by Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2023-05-30 under approval number K230909. 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™ Ultrasound Biopsy Needle (ECHO-BX-3-22)?

EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) is a medical device that received FDA 510(k) clearance on 2023-05-30. It is manufactured by Cook Ireland, Ltd.. The 510(k) number is K230909.

When was EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) approved by the FDA?

EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) received FDA 510(k) clearance on 2023-05-30, under approval number K230909.

What company makes EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)?

EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) is manufactured by Cook Ireland, Ltd..

What is the FDA product code for EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)?

The FDA product code for EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) is FCG.

Related Clinical Trials

NCT07612644 Hemorrhage Elimination During Lumbar Puncture Using Ultrasound Measurements (HELPUS) RECRUITING NCT06626022 Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging. RECRUITING NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT03503643 Hemi-Gland Cryoablation for Prostate Cancer at UCLA COMPLETED

Other Devices by Cook Ireland, Ltd.

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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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