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FDA 510(k)

VACUUM ASSISTED CORE BIOPSY DEVICE

K-Number: K034021 · 2004-09-08

ApplicantSuros Surgical Systems, Inc.
Decision Date2004-09-08
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 Suros Surgical Systems, Inc.. It received FDA 510(k) clearance on 2004-09-08 under 510(k) number K034021. 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 2004-09-08. The listed applicant is Suros Surgical Systems, Inc.. The 510(k) number is K034021.

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

VACUUM ASSISTED CORE BIOPSY DEVICE received FDA 510(k) clearance on 2004-09-08, under 510(k) number K034021.

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

The FDA 510(k) record lists Suros Surgical Systems, 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.

Related Clinical Trials

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.

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Other records listing Suros Surgical Systems, 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.

K062528TISSUE SITE MARKING SYSTEMK042290VACUUM ASSISTED CORE BIOPSY DEVICE

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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