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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 the device name listed in this FDA 510(k) record. The listed applicant is Ranfac Corporation. It received FDA 510(k) clearance on 2019-04-25 under 510(k) 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. The listed applicant is Ranfac Corporation. The 510(k) number is K183146.

When did Ranfac Cartilage Biopsy Needle receive FDA 510(k) clearance?

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

Who is the listed applicant for Ranfac Cartilage Biopsy 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 Ranfac Cartilage Biopsy Needle?

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

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.

K223612Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)K202287Ran-Flex-B Bone Marrow Aspiration NeedleK190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,K162932Ranfac 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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