Cleared Traditional

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

K241209 · Cook Ireland, Ltd. · Gastroenterology & Urology
Jul 2024
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K241209 is an FDA 510(k) clearance for the EchoTip AcuCore? EUS Biopsy Needle (ECHO-BX-19), a Biopsy Needle (Class II — Special Controls, product code FCG), submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on July 29, 2024, 90 days after receiving the submission on April 30, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K241209 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2024
Decision Date July 29, 2024
Days to Decision 90 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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