Cleared Traditional

M?Biopsy /SureCore Automatic Disposable Biopsy Needle, M?Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M?Biopsy /SureAim Coaxial Biopsy Needle

K233031 · Canyon Medical, Inc. · General & Plastic Surgery
Jan 2024
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K233031 is an FDA 510(k) clearance for the M?Biopsy /SureCore Automatic Disposable Biopsy Needle, M?Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M?Biopsy /SureAim Coaxial Biopsy Needle, a Instrument, Biopsy (Class II — Special Controls, product code KNW), submitted by Canyon Medical, Inc. (Nanjing, CN). The FDA issued a Cleared decision on January 17, 2024, 114 days after receiving the submission on September 25, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K233031 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2023
Decision Date January 17, 2024
Days to Decision 114 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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