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FDA 510(k)

PERCUTANEOUS BREAST BIOPSY (PBB)

K-Number: K972328 · 1998-07-07

ApplicantUrothealth System, Inc.
Decision Date1998-07-07
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PERCUTANEOUS BREAST BIOPSY (PBB) is the device name listed in this FDA 510(k) record. The listed applicant is Urothealth System, Inc.. It received FDA 510(k) clearance on 1998-07-07 under 510(k) number K972328. 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 PERCUTANEOUS BREAST BIOPSY (PBB)?

PERCUTANEOUS BREAST BIOPSY (PBB) is a medical device that received FDA 510(k) clearance on 1998-07-07. The listed applicant is Urothealth System, Inc.. The 510(k) number is K972328.

When did PERCUTANEOUS BREAST BIOPSY (PBB) receive FDA 510(k) clearance?

PERCUTANEOUS BREAST BIOPSY (PBB) received FDA 510(k) clearance on 1998-07-07, under 510(k) number K972328.

Who is the listed applicant for PERCUTANEOUS BREAST BIOPSY (PBB)?

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

What is the FDA product code for PERCUTANEOUS BREAST BIOPSY (PBB)?

The FDA product code for PERCUTANEOUS BREAST BIOPSY (PBB) is KNW.

Related Clinical Trials

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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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