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FDA 510(k)

Medax Biopsy Systems III

K-Number: K181803 · 2018-10-18

ApplicantMedax Srl Unipersonale
Decision Date2018-10-18
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Medax Biopsy Systems III is a medical device manufactured by Medax Srl Unipersonale. It received FDA 510(k) clearance on 2018-10-18 under approval number K181803. 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 Medax Biopsy Systems III?

Medax Biopsy Systems III is a medical device that received FDA 510(k) clearance on 2018-10-18. It is manufactured by Medax Srl Unipersonale. The 510(k) number is K181803.

When was Medax Biopsy Systems III approved by the FDA?

Medax Biopsy Systems III received FDA 510(k) clearance on 2018-10-18, under approval number K181803.

What company makes Medax Biopsy Systems III?

Medax Biopsy Systems III is manufactured by Medax Srl Unipersonale.

What is the FDA product code for Medax Biopsy Systems III?

The FDA product code for Medax Biopsy Systems III is KNW.

Related Clinical Trials

NCT07234188 POM vs HFNC for Hypoxemia Prevention in Children COMPLETED

Other Devices by Medax Srl Unipersonale

K172344Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) 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 K192101Medone Ultra, Medextra

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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