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FDA 510(k)

TRU-CORE NEEDLE SET

K-Number: K943368 · 1994-07-29

ApplicantIdeamatrix
Decision Date1994-07-29
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRU-CORE NEEDLE SET is the device name listed in this FDA 510(k) record. The listed applicant is Ideamatrix. It received FDA 510(k) clearance on 1994-07-29 under 510(k) number K943368. 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 TRU-CORE NEEDLE SET?

TRU-CORE NEEDLE SET is a medical device that received FDA 510(k) clearance on 1994-07-29. The listed applicant is Ideamatrix. The 510(k) number is K943368.

When did TRU-CORE NEEDLE SET receive FDA 510(k) clearance?

TRU-CORE NEEDLE SET received FDA 510(k) clearance on 1994-07-29, under 510(k) number K943368.

Who is the listed applicant for TRU-CORE NEEDLE SET?

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

What is the FDA product code for TRU-CORE NEEDLE SET?

The FDA product code for TRU-CORE NEEDLE SET 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 Ideamatrix 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.

K945921ECHO STAR NEEDLE SET

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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