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FDA 510(k)

Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)

K-Number: K223612 · 2023-02-21

ApplicantRanfac Corporation
Decision Date2023-02-21
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) is the device name listed in this FDA 510(k) record. The listed applicant is Ranfac Corporation. It received FDA 510(k) clearance on 2023-02-21 under 510(k) number K223612. 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 Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)?

Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) is a medical device that received FDA 510(k) clearance on 2023-02-21. The listed applicant is Ranfac Corporation. The 510(k) number is K223612.

When did Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) receive FDA 510(k) clearance?

Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) received FDA 510(k) clearance on 2023-02-21, under 510(k) number K223612.

Who is the listed applicant for Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)?

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 Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)?

The FDA product code for Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) 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.

NCT05258357Landmark vs. Ultrasound-Assisted Bone Marrow Biopsy Procedure StudyCOMPLETEDNCT02299102Comparing Powered Ported Bone Marrow Aspiration to Manual Standard Bone Marrow Aspiration ProceduresCOMPLETEDNCT03626285Bone Marrow Transplantation Using CD34-Selected Stem Cells From Related or Unrelated Donors in Treating Participants With Cancer or Other DisordersAVAILABLENCT05078853Thyroglobulin Point of Care Assay for Rapid Detection of Metastatic Differentiated Thyroid CarcinomaCOMPLETEDNCT06388993Marrow Cellution™ vs. Traditional BMA Harvest ProjectRECRUITING

Other records listing Ranfac Corporation 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.

K202287Ran-Flex-B Bone Marrow Aspiration NeedleK190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,K183146Ranfac Cartilage Biopsy NeedleK162932Ranfac Fat Aspiration Cannula

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

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