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FDA 510(k)

Disposable Biopsy Needle

K-Number: K244018 · 2025-07-22

ApplicantZhejiang Curaway Medical Technology Co., Ltd.
Decision Date2025-07-22
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Biopsy Needle is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-22 under 510(k) number K244018. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Biopsy Needle?

Disposable Biopsy Needle is a medical device that received FDA 510(k) clearance on 2025-07-22. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. The 510(k) number is K244018.

When did Disposable Biopsy Needle receive FDA 510(k) clearance?

Disposable Biopsy Needle received FDA 510(k) clearance on 2025-07-22, under 510(k) number K244018.

Who is the listed applicant for Disposable Biopsy Needle?

The FDA 510(k) record lists Zhejiang Curaway Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Biopsy Needle?

The FDA product code for Disposable Biopsy Needle is KNW.

Other records listing Zhejiang Curaway Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242322Bone Marrow Biopsy NeedleK241793Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy NeedleK240758Radiofrequency Generator System, Cura RF ElectrodeK232505Endovenous Radiofrequency Generator, Endovenous Radiofrequency CatheterK222001Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe

Related Devices (Code: KNW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.K260572Marrow MarxmanMedimetrix, LLCK261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery CharDevicor Medical Products, Inc.K252795ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with CoaxialArgon Medical Devices, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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