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FDA 510(k)

VACUUM ASSISTED CORE BIOPSY DEVICE

K-Number: K010400 · 2001-07-24

ApplicantPromex, Inc.
Decision Date2001-07-24
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VACUUM ASSISTED CORE BIOPSY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Promex, Inc.. It received FDA 510(k) clearance on 2001-07-24 under 510(k) number K010400. 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 VACUUM ASSISTED CORE BIOPSY DEVICE?

VACUUM ASSISTED CORE BIOPSY DEVICE is a medical device that received FDA 510(k) clearance on 2001-07-24. The listed applicant is Promex, Inc.. The 510(k) number is K010400.

When did VACUUM ASSISTED CORE BIOPSY DEVICE receive FDA 510(k) clearance?

VACUUM ASSISTED CORE BIOPSY DEVICE received FDA 510(k) clearance on 2001-07-24, under 510(k) number K010400.

Who is the listed applicant for VACUUM ASSISTED CORE BIOPSY DEVICE?

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

What is the FDA product code for VACUUM ASSISTED CORE BIOPSY DEVICE?

The FDA product code for VACUUM ASSISTED CORE BIOPSY DEVICE is KNW.

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Other records listing Promex, 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.

K023450BIOPSY SITE TISSUE MARKER DEVICEK022634CO-AXIAL INTRODUCER NEEDLEK011270AUTOMATED CORE BIOPSY DEVICEK001132BONE BIOPSY NEEDLEK994272AUTOMATED CORE BIOPSY DEVICEK993435MANUAL BONE MARROW BIOPSY DEVICE

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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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