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Disposable Biopsy Needle

by Zhejiang CuraWay Medical Technology Co., Ltd.

510(k) K244018

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

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) K244018↗

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 NumberK244018 Date22 Jul 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  • Withdrawn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.

The Disposable Biopsy Needle is a single-use, core needle biopsy device designed for obtaining tissue samples from soft tissues, organs, or lesions. It is classified under the nomenclature for core needle biopsy instruments, enabling minimally invasive diagnostic procedures in clinical settings such as radiology, urology, or gastroenterology.

This device is supplied sterile and intended for one-time use only, adhering to FDA 510(k) clearance under the product code KNW. It is regulated under the Medical Device Regulation (MDR) and is intended for use in controlled environments such as operating rooms, imaging suites, or procedural clinics. No MRI safety information or reusable specifications are noted in the data.

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