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FDA 510(k)

VACUFLASH BIOPSY SYSTEM

K-Number: K024089 · 2003-03-11

ApplicantBip USA, Inc.
Decision Date2003-03-11
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VACUFLASH BIOPSY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bip USA, Inc.. It received FDA 510(k) clearance on 2003-03-11 under 510(k) number K024089. 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 VACUFLASH BIOPSY SYSTEM?

VACUFLASH BIOPSY SYSTEM is a medical device that received FDA 510(k) clearance on 2003-03-11. The listed applicant is Bip USA, Inc.. The 510(k) number is K024089.

When did VACUFLASH BIOPSY SYSTEM receive FDA 510(k) clearance?

VACUFLASH BIOPSY SYSTEM received FDA 510(k) clearance on 2003-03-11, under 510(k) number K024089.

Who is the listed applicant for VACUFLASH BIOPSY SYSTEM?

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

What is the FDA product code for VACUFLASH BIOPSY SYSTEM?

The FDA product code for VACUFLASH BIOPSY SYSTEM 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.

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Other records listing Bip USA, Inc. 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.

K934371BIP MULTI MODIFICATIONK934370BIP BIOPSY NEEDLE MODIFICATIONK935457LOCALIZATION WIRE OR MARKER - SURGICALK925870SPACERK925875HORIZONTAL NEEDLE GUIDE ATTACHMENTK925874BREAST STABILIZER

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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.

K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd.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.

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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