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FDA 510(k)

Ranfac Cartilage Biopsy Needle

K-Number: K183146 · 2019-04-25

ApplicantRanfac Corporation
Decision Date2019-04-25
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Ranfac Cartilage Biopsy Needle is a medical device manufactured by Ranfac Corporation. It received FDA 510(k) clearance on 2019-04-25 under approval number K183146. 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 Cartilage Biopsy Needle?

Ranfac Cartilage Biopsy Needle is a medical device that received FDA 510(k) clearance on 2019-04-25. It is manufactured by Ranfac Corporation. The 510(k) number is K183146.

When was Ranfac Cartilage Biopsy Needle approved by the FDA?

Ranfac Cartilage Biopsy Needle received FDA 510(k) clearance on 2019-04-25, under approval number K183146.

What company makes Ranfac Cartilage Biopsy Needle?

Ranfac Cartilage Biopsy Needle is manufactured by Ranfac Corporation.

What is the FDA product code for Ranfac Cartilage Biopsy Needle?

The FDA product code for Ranfac Cartilage Biopsy Needle is KNW.

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Other Devices by Ranfac Corporation

K190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, K202287Ran-Flex-B Bone Marrow Aspiration 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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