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FDA 510(k)

Medone Ultra, Medextra

K-Number: K192101 · 2020-04-02

ApplicantMedax Srl Unipersonale
Decision Date2020-04-02
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Medone Ultra, Medextra is a medical device manufactured by Medax Srl Unipersonale. It received FDA 510(k) clearance on 2020-04-02 under approval number K192101. 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 Medone Ultra, Medextra?

Medone Ultra, Medextra is a medical device that received FDA 510(k) clearance on 2020-04-02. It is manufactured by Medax Srl Unipersonale. The 510(k) number is K192101.

When was Medone Ultra, Medextra approved by the FDA?

Medone Ultra, Medextra received FDA 510(k) clearance on 2020-04-02, under approval number K192101.

What company makes Medone Ultra, Medextra?

Medone Ultra, Medextra is manufactured by Medax Srl Unipersonale.

What is the FDA product code for Medone Ultra, Medextra?

The FDA product code for Medone Ultra, Medextra is KNW.

Other Devices by Medax Srl Unipersonale

K172344Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) K181803Medax Biopsy Systems III K192099MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System

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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