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FDA 510(k)

VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD)

K-Number: K904987 · 1991-02-11

ApplicantVibronics
Decision Date1991-02-11
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD) is the device name listed in this FDA 510(k) record. The listed applicant is Vibronics. It received FDA 510(k) clearance on 1991-02-11 under 510(k) number K904987. 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 VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD)?

VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD) is a medical device that received FDA 510(k) clearance on 1991-02-11. The listed applicant is Vibronics. The 510(k) number is K904987.

When did VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD) receive FDA 510(k) clearance?

VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD) received FDA 510(k) clearance on 1991-02-11, under 510(k) number K904987.

Who is the listed applicant for VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD)?

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

What is the FDA product code for VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD)?

The FDA product code for VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD) is KNW.

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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

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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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