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

by Canyon Medical Inc.

510(k) K233031

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K233031↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK233031 Date17 Jan 2024ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
KNW
FDA applicant
Canyon Medical, Inc.
Device Class
Class II
Regulation
21 CFR Part 876.1075
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The M·Biopsy SureCore Automatic and Semi-automatic Disposable Biopsy Needles, along with the M·Biopsy SureAim Coaxial Biopsy Needle, are core needle biopsy instruments designed for tissue sampling. These devices are classified under the category of biopsy needles, enabling precise extraction of tissue samples for diagnostic purposes in procedures such as core needle biopsy. The SureCore models feature automatic and semi-automatic mechanisms for controlled tissue acquisition, while the SureAim Coaxial Biopsy Needle incorporates a coaxial design for enhanced accuracy and stability.

These devices are intended for single-use and are supplied sterile, adhering to FDA 510(k) clearance under the Medical Device Directive (MDD) and Medical Device Regulation (MDR). They are regulated under product code KNW and are categorized under the Gastroenterology and Urology advisory committees. The SureCore Automatic and Semi-automatic models, as well as the SureAim Coaxial model, are manufactured by Canyon Medical Inc. and are designed for use in clinical settings requiring precise tissue sampling procedures.

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