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FDA 510(k)

Ran-Flex-B Bone Marrow Aspiration Needle

K-Number: K202287 · 2020-09-18

ApplicantRanfac Corporation
Decision Date2020-09-18
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Ran-Flex-B Bone Marrow Aspiration Needle is a medical device manufactured by Ranfac Corporation. It received FDA 510(k) clearance on 2020-09-18 under approval 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. It is manufactured by Ranfac Corporation. The 510(k) number is K202287.

When was Ran-Flex-B Bone Marrow Aspiration Needle approved by the FDA?

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

What company makes Ran-Flex-B Bone Marrow Aspiration Needle?

Ran-Flex-B Bone Marrow Aspiration Needle is manufactured by Ranfac Corporation.

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

NCT02299102 Comparing Powered Ported Bone Marrow Aspiration to Manual Standard Bone Marrow Aspiration Procedures COMPLETED NCT07577232 Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess RECRUITING NCT05078853 Thyroglobulin Point of Care Assay for Rapid Detection of Metastatic Differentiated Thyroid Carcinoma COMPLETED NCT02872831 Beacon BNX™ Endoscopic Ultrasound (EUS)-Needle vs SharkCore™ Needle WITHDRAWN

Other Devices by Ranfac Corporation

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

Related Devices (Code: KNW)

K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer NeedlesM.D.L. S.R.L. K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer StyletDevicor Medical Products, Inc. K161234CASSI II Rotational Core Biopsy SystemScion Medical Technologies, LLC K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for SemMermaid Medical A/S K161805EnCor MRI Introducer Set, EnCor Probe IntroducerSenorx, Inc. K153337Corvocet Biopsy SystemMerit Medical Systems, Inc.

Official Source

View on FDA Database →

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

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