FDA 510(k)

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

Numéro K : K230909 · 2023-05-30

Date de décision2023-05-30

Code produitFCG

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) 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 2023-05-30 under 510(k) number K230909. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Cook Ireland, Ltd.. The 510(k) number is K230909.

When did EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) receive FDA 510(k) clearance?

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

Who is the listed applicant for EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)?

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™ Ultrasound Biopsy Needle (ECHO-BX-3-22)?

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

Essais cliniques associés

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Autres dossiers indiquant Cook Ireland, Ltd. en tant que demandeur

K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)K233079Zimmon® 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)K213946Compass BDS Biliary Stent K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle K182980Zilver 518 Biliary Stent, Zilver 635 Biliary Stent

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Dispositifs connexes (Code : FCG)

K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.K231422Precision GILimaca Medical, Ltd.K231267ClearTipFinemedix Co., Ltd.K212423EndoDrill® Model XBibbinstruments AB

Source officielle

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