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

by Zhejiang CuraWay Medical Technology Co., Ltd.

510(k) K241793

Active European Union and United States

CE MDR 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) K241793↗

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 NumberK241793 Date24 Jan 2025ClearedStatusActive
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  • Withdrawn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/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
KNW
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.

This device is a Disposable Coaxial Biopsy Needle, classified under the Automatic Core Biopsy Instrument and Semi-Automatic Core Biopsy Instrument categories. It is designed for obtaining tissue samples from soft tissues, organs, or lesions via percutaneous or transrectal biopsy procedures, ensuring precise and controlled tissue acquisition for histopathological examination.

The instrument is supplied as a single-use, disposable coaxial needle system, intended for use in clinical settings such as radiology, urology, and gastroenterology. It is not intended for MRI use and must be handled with sterile technique. The device is authorised under FDA 510K and MDR, with a Traditional 510(k) clearance (K241793) and falls under the KNW product code. Storage and handling must comply with manufacturer guidelines to maintain sterility and functionality.

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