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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 the device name listed in this FDA 510(k) record. The listed applicant is Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2024-07-29 under 510(k) 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. The listed applicant is Cook Ireland, Ltd.. The 510(k) number is K241209.

When did EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) receive FDA 510(k) clearance?

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

Who is the listed applicant for EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)?

The FDA 510(k) record lists Cook Ireland, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02872831Beacon BNX™ Endoscopic Ultrasound (EUS)-Needle vs SharkCore™ NeedleWITHDRAWNNCT07240818Comparison of FNB to EUS-CNB for Pancreatic LesionsNOT_YET_RECRUITINGNCT07274657Superb Microvascular Imaging (SMI) and Two-Dimensional Endoscopic Ultrasound Guided Shear Wave Elastography (2D-SWE-EUS) in Differential Diagnosis of Pancreatic Adenocarcinoma (PA) From Other Pancreatic Solid Lesions (PSLs) and Pancreatic neuroendocrinE Tumors (pNETs) MalignancyRECRUITING

Other records listing Cook Ireland, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm ScopesPMA P200023Stent, iliac veinPMA P050017STENT, ILIACPMA P100022Stent, superficial femoral artery, drug-elutingK233079Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)

View all 20 devices →

Related Devices (Code: FCG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.K231422Precision GILimaca Medical, Ltd.K231267ClearTipFinemedix Co., Ltd.K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.K212423EndoDrill® Model XBibbinstruments AB

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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