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FDA 510(k)

Uramix CuraWay Biopsy Needle

K-Number: K203141 · 2021-09-17

ApplicantUramix, Inc.
Decision Date2021-09-17
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Uramix CuraWay Biopsy Needle is the device name listed in this FDA 510(k) record. The listed applicant is Uramix, Inc.. It received FDA 510(k) clearance on 2021-09-17 under 510(k) number K203141. 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 Uramix CuraWay Biopsy Needle?

Uramix CuraWay Biopsy Needle is a medical device that received FDA 510(k) clearance on 2021-09-17. The listed applicant is Uramix, Inc.. The 510(k) number is K203141.

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

Uramix CuraWay Biopsy Needle received FDA 510(k) clearance on 2021-09-17, under 510(k) number K203141.

Who is the listed applicant for Uramix CuraWay Biopsy Needle?

The FDA 510(k) record lists Uramix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Uramix CuraWay Biopsy Needle?

The FDA product code for Uramix CuraWay Biopsy Needle is KNW.

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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