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FDA 510(k)

Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices

K-Number: K201244 · 2020-08-07

ApplicantTransmed7, LLC
Decision Date2020-08-07
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices is the device name listed in this FDA 510(k) record. The listed applicant is Transmed7, LLC. It received FDA 510(k) clearance on 2020-08-07 under 510(k) number K201244. 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 Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices?

Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices is a medical device that received FDA 510(k) clearance on 2020-08-07. The listed applicant is Transmed7, LLC. The 510(k) number is K201244.

When did Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices receive FDA 510(k) clearance?

Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices received FDA 510(k) clearance on 2020-08-07, under 510(k) number K201244.

Who is the listed applicant for Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices?

The FDA 510(k) record lists Transmed7, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices?

The FDA product code for Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices 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.

NCT03896620Recognition of Circulating Tumor DNA in Soft Tissue SarcomaACTIVE_NOT_RECRUITINGNCT05561920Phonatory Movement of the Pharyngoesophageal Mucosa in Laryngectomy PatientsCOMPLETEDNCT06636136Transtibial OsseointegrationRECRUITINGNCT06904066Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic MalignanciesRECRUITINGNCT07220239Menstrual Cup for Early Endometrial Cancer Detection in Lynch SyndromeRECRUITINGNCT07586163Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse DeficiencyACTIVE_NOT_RECRUITING

Other records listing Transmed7, LLC 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.

K173316SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue 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.

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.K252795ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with CoaxialArgon Medical Devices, Inc.

Official Source

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