FDA 510(k)

Ran-Flex-B Bone Marrow Aspiration Needle

N.º K: K202287 · 2020-09-18

Fecha de decisión2020-09-18

Código de productoKNW

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Ran-Flex-B Bone Marrow Aspiration Needle is the device name listed in this FDA 510(k) record. The listed applicant is Ranfac Corporation. It received FDA 510(k) clearance on 2020-09-18 under 510(k) number K202287. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Ran-Flex-B Bone Marrow Aspiration Needle?

Ran-Flex-B Bone Marrow Aspiration Needle is a medical device that received FDA 510(k) clearance on 2020-09-18. The listed applicant is Ranfac Corporation. The 510(k) number is K202287.

When did Ran-Flex-B Bone Marrow Aspiration Needle receive FDA 510(k) clearance?

Ran-Flex-B Bone Marrow Aspiration Needle received FDA 510(k) clearance on 2020-09-18, under 510(k) number K202287.

Who is the listed applicant for Ran-Flex-B Bone Marrow Aspiration Needle?

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

What is the FDA product code for Ran-Flex-B Bone Marrow Aspiration Needle?

The FDA product code for Ran-Flex-B Bone Marrow Aspiration Needle is KNW.

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Otros registros que enlistan a Ranfac Corporation como solicitante

K223612Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)K190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,K183146Ranfac Cartilage Biopsy Needle

Dispositivos relacionados (Código: KNW)

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, LLC K261196Promisemed 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.

Fuente oficial

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