Cleared Traditional

Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle

K241793 · Zhejiang Curaway Medical Technology Co., Ltd. · General & Plastic Surgery
Jan 2025
Decision
217d
Days
Class 2
Risk

About This 510(k) Submission

K241793 is an FDA 510(k) clearance for the Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle, a Instrument, Biopsy (Class II — Special Controls, product code KNW), submitted by Zhejiang Curaway Medical Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on January 24, 2025, 217 days after receiving the submission on June 21, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K241793 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2024
Decision Date January 24, 2025
Days to Decision 217 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KNW — Instrument, Biopsy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1075

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