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FDA 510(k)

CARIS MINITOME BIOPSY INSTRUMENT

K-Number: K020024 · 2002-04-03

ApplicantArtemis Medical, Inc.
Decision Date2002-04-03
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CARIS MINITOME BIOPSY INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Artemis Medical, Inc.. It received FDA 510(k) clearance on 2002-04-03 under 510(k) number K020024. 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 CARIS MINITOME BIOPSY INSTRUMENT?

CARIS MINITOME BIOPSY INSTRUMENT is a medical device that received FDA 510(k) clearance on 2002-04-03. The listed applicant is Artemis Medical, Inc.. The 510(k) number is K020024.

When did CARIS MINITOME BIOPSY INSTRUMENT receive FDA 510(k) clearance?

CARIS MINITOME BIOPSY INSTRUMENT received FDA 510(k) clearance on 2002-04-03, under 510(k) number K020024.

Who is the listed applicant for CARIS MINITOME BIOPSY INSTRUMENT?

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

What is the FDA product code for CARIS MINITOME BIOPSY INSTRUMENT?

The FDA product code for CARIS MINITOME BIOPSY INSTRUMENT is KNW.

Related Clinical Trials

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Other records listing Artemis Medical, 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.

K03221714G CORMARK BIOPSY SITE IDENTIFIERK003777CARIS SITE MARKER

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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