Cleared Traditional

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

K230909 · Cook Ireland, Ltd. · Gastroenterology & Urology
May 2023
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K230909 is an FDA 510(k) clearance for the EchoTip? AcuCore? Ultrasound Biopsy Needle (ECHO-BX-3-22), a Biopsy Needle (Class II — Special Controls, product code FCG), submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on May 30, 2023, 60 days after receiving the submission on March 31, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K230909 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2023
Decision Date May 30, 2023
Days to Decision 60 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FCG — Biopsy Needle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1075

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