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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) K222865

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) K222865↗

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 NumberK222865 Date3 Apr 2023ClearedStatusActive
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  • Withdrawn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 and SureAim needles are disposable biopsy instruments designed for percutaneous tissue acquisition. These devices fall under the category of biopsy needles, featuring automated or semi-automated mechanisms to facilitate precise tissue sampling in clinical settings. The SureCore models provide automatic or semi-automatic actuation for controlled core needle biopsy procedures, while the SureAim Coaxial Biopsy Needle incorporates a coaxial design for enhanced accuracy during sampling.

These devices are intended for single-use and are supplied sterile, ensuring compliance with medical standards for aseptic procedures. They are classified under the product code KNW and are regulated under FDA 510(k) clearance, MDD, and MDR. The needles are available in various configurations to accommodate different clinical applications, with no specific MRI safety restrictions noted. Proper storage adheres to standard sterile packaging guidelines to maintain integrity until use.

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See all devices from Canyon Medical Inc. →

Questions

AI-generated answers, 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.

  • Are these biopsy needles designed for reuse or are they intended for single-use only?

    These devices are explicitly designed for single-use only. The product description and specifications confirm they are supplied sterile and intended to maintain aseptic standards during clinical procedures, which is a key requirement for disposable medical instruments.

  • What types of clinical procedures are these needles primarily used for, and how do their designs differ?

    These needles are designed for percutaneous tissue acquisition, commonly used in core needle biopsy procedures. The SureCore models (automatic and semi-automatic) provide controlled actuation for precise sampling, while the SureAim Coaxial Biopsy Needle features a coaxial design to enhance accuracy during tissue extraction. The design differences cater to varying clinical needs, such as improved guidance or automated force application.

  • How should these needles be stored to ensure they remain sterile until use?

    The needles must be stored according to standard sterile packaging guidelines to preserve their integrity. Since they are supplied sterile and intended for single-use, the packaging should remain unopened and protected from contamination until immediately before use, following manufacturer-recommended storage conditions.

  • Are there any specific size or model variations available for these biopsy needles, and how might they be selected?

    While the exact sizes or model variations aren’t detailed in the provided data, the description mentions these needles are available in various configurations to accommodate different clinical applications. Selection would typically depend on factors like tissue type, target depth, and procedural requirements, though specific gauges or lengths would need to be confirmed with the manufacturer or product documentation.

  • What regulatory pathways have these devices undergone, and which committees were involved in their review?

    These devices have undergone FDA 510(k) clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) reviews. The FDA submission was reviewed by the Gastroenterology and Urology advisory committees (listed under the GU review panel), with a decision classified as *Substantially Equivalent* (SESE) under the traditional clearance type.