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FDA 510(k)

DAUM MRI/CONVENTIONAL BIOPSY KIT

K-Number: K991366 · 1999-06-25

ApplicantDaum GmbH
Decision Date1999-06-25
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DAUM MRI/CONVENTIONAL BIOPSY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Daum GmbH. It received FDA 510(k) clearance on 1999-06-25 under 510(k) number K991366. 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 DAUM MRI/CONVENTIONAL BIOPSY KIT?

DAUM MRI/CONVENTIONAL BIOPSY KIT is a medical device that received FDA 510(k) clearance on 1999-06-25. The listed applicant is Daum GmbH. The 510(k) number is K991366.

When did DAUM MRI/CONVENTIONAL BIOPSY KIT receive FDA 510(k) clearance?

DAUM MRI/CONVENTIONAL BIOPSY KIT received FDA 510(k) clearance on 1999-06-25, under 510(k) number K991366.

Who is the listed applicant for DAUM MRI/CONVENTIONAL BIOPSY KIT?

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

What is the FDA product code for DAUM MRI/CONVENTIONAL BIOPSY KIT?

The FDA product code for DAUM MRI/CONVENTIONAL BIOPSY KIT is KNW.

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Other records listing Daum GmbH 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.

K010037DAUM DOUBLE-SHOOT BISOPSY GUNK990782DAUM NEUROGATE TROCARK970037TARGOGRID

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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