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FDA 510(k)

EleVation Breast Biopsy System

K-Number: K211933 · 2021-07-15

ApplicantBard Peripheral Vascular
Decision Date2021-07-15
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EleVation Breast Biopsy System is the device name listed in this FDA 510(k) record. The listed applicant is Bard Peripheral Vascular. It received FDA 510(k) clearance on 2021-07-15 under 510(k) number K211933. 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 EleVation Breast Biopsy System?

EleVation Breast Biopsy System is a medical device that received FDA 510(k) clearance on 2021-07-15. The listed applicant is Bard Peripheral Vascular. The 510(k) number is K211933.

When did EleVation Breast Biopsy System receive FDA 510(k) clearance?

EleVation Breast Biopsy System received FDA 510(k) clearance on 2021-07-15, under 510(k) number K211933.

Who is the listed applicant for EleVation Breast Biopsy System?

The FDA 510(k) record lists Bard Peripheral Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EleVation Breast Biopsy System?

The FDA product code for EleVation Breast Biopsy System is KNW.

Other records listing Bard Peripheral Vascular 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.

K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemPMA P130029System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatmentPMA P180037Stent, iliac veinPMA P070014STENT, SUPERFICIAL FEMORAL ARTERYK260012UltraScore™ Focused Force PTA BalloonK252681EnCor EnCompass™ Breast Biopsy and Tissue Removal System

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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

View on FDA Database →

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

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