Cleared Traditional

ClearTip

K231267 · Finemedix Co., Ltd. · Gastroenterology & Urology
Jun 2023
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K231267 is an FDA 510(k) clearance for the ClearTip, a Biopsy Needle (Class II — Special Controls, product code FCG), submitted by Finemedix Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on June 30, 2023, 59 days after receiving the submission on May 2, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K231267 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2023
Decision Date June 30, 2023
Days to Decision 59 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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