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FDA 510(k)

MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE

K-Number: K981477 · 1998-06-10

ApplicantMedical Biopsy, Inc.
Decision Date1998-06-10
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Biopsy, Inc.. It received FDA 510(k) clearance on 1998-06-10 under 510(k) number K981477. 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 MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE?

MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE is a medical device that received FDA 510(k) clearance on 1998-06-10. The listed applicant is Medical Biopsy, Inc.. The 510(k) number is K981477.

When did MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE receive FDA 510(k) clearance?

MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE received FDA 510(k) clearance on 1998-06-10, under 510(k) number K981477.

Who is the listed applicant for MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE?

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

What is the FDA product code for MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE?

The FDA product code for MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE 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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