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FDA 510(k)

MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST

K-Number: K030443 · 2003-05-09

ApplicantNastech Pharmaceutical Company, Inc.
Decision Date2003-05-09
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Nastech Pharmaceutical Company, Inc.. It received FDA 510(k) clearance on 2003-05-09 under 510(k) number K030443. 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 MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST?

MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST is a medical device that received FDA 510(k) clearance on 2003-05-09. The listed applicant is Nastech Pharmaceutical Company, Inc.. The 510(k) number is K030443.

When did MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST receive FDA 510(k) clearance?

MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST received FDA 510(k) clearance on 2003-05-09, under 510(k) number K030443.

Who is the listed applicant for MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST?

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

What is the FDA product code for MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST?

The FDA product code for MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST is KNW.

Related Clinical Trials

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Other records listing Nastech Pharmaceutical Company, 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.

K012088NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT

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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