FDA 510(k)

Automatic Core Biopsy Instrument

K-Number: K260517 · 2026-08-28

ApplicantZhejiang Curaway Medical Technology Co., Ltd.

Decision Date2026-08-28

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Automatic Core Biopsy Instrument 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 2026-08-28 under 510(k) number K260517. 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 Automatic Core Biopsy Instrument?

Automatic Core Biopsy Instrument is a medical device that received FDA 510(k) clearance on 2026-08-28. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. The 510(k) number is K260517.

When did Automatic Core Biopsy Instrument receive FDA 510(k) clearance?

Automatic Core Biopsy Instrument received FDA 510(k) clearance on 2026-08-28, under 510(k) number K260517.

Who is the listed applicant for Automatic Core Biopsy Instrument?

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 Automatic Core Biopsy Instrument?

The FDA product code for Automatic Core Biopsy Instrument is KNW.

Related Clinical Trials

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.

NCT07800013Full Core Biopsy Needle vs Side Notch Biopsy NeedleCOMPLETED

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Related Devices (Code: KNW)

K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.K260572Marrow MarxmanMedimetrix, LLC K261196Promisemed 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

View on FDA Database →

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