FDA 510(k)

Ran-Flex-B Bone Marrow Aspiration Needle

K-Number: K202287 · 2020-09-18

Decision Date2020-09-18

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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.

NCT02299102Comparing Powered Ported Bone Marrow Aspiration to Manual Standard Bone Marrow Aspiration ProceduresCOMPLETED NCT05258357Landmark vs. Ultrasound-Assisted Bone Marrow Biopsy Procedure StudyCOMPLETED NCT06988020"Pseudo-scanner" MRI Sequences for the Detection of Bone Lesions in Multiple MyelomaRECRUITING

Other records listing Ranfac Corporation as applicant

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 K162932Ranfac Fat Aspiration Cannula

Related Devices (Code: KNW)

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.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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.