FDA 510(k)

Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System

K-Number: K202012 · 2020-08-18

Decision Date2020-08-18

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System is a medical device manufactured by Devicor Medical Products, Inc.. It received FDA 510(k) clearance on 2020-08-18 under approval number K202012. 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 Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System?

Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System is a medical device that received FDA 510(k) clearance on 2020-08-18. It is manufactured by Devicor Medical Products, Inc.. The 510(k) number is K202012.

When was Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System approved by the FDA?

Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System received FDA 510(k) clearance on 2020-08-18, under approval number K202012.

What company makes Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System?

Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System is manufactured by Devicor Medical Products, Inc..

What is the FDA product code for Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System?

The FDA product code for Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System is KNW.

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Related PubMed Literature

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Other Devices by Devicor Medical Products, Inc.

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 Stylet K161021HydroMARK Breast Biopsy Site Marker K152989Mammotome revolve Dual Vacuum Assist Biopsy System K170803HydroMARK Breast Biopsy Site Markers K203097HydroMARK Breast Biopsy Site Markers K210752HydroMARK Breast Biopsy Site Marker

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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

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