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FDA 510(k)

Mammotome revolve Dual Vacuum Assist Biopsy System

K-Number: K152989 · 2016-02-25

ApplicantDevicor Medical Products, Inc.
Decision Date2016-02-25
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Mammotome revolve Dual Vacuum Assist Biopsy System is a medical device manufactured by Devicor Medical Products, Inc.. It received FDA 510(k) clearance on 2016-02-25 under approval number K152989. 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 Assist Biopsy System?

Mammotome revolve Dual Vacuum Assist Biopsy System is a medical device that received FDA 510(k) clearance on 2016-02-25. It is manufactured by Devicor Medical Products, Inc.. The 510(k) number is K152989.

When was Mammotome revolve Dual Vacuum Assist Biopsy System approved by the FDA?

Mammotome revolve Dual Vacuum Assist Biopsy System received FDA 510(k) clearance on 2016-02-25, under approval number K152989.

What company makes Mammotome revolve Dual Vacuum Assist Biopsy System?

Mammotome revolve Dual Vacuum Assist Biopsy System is manufactured by Devicor Medical Products, Inc..

What is the FDA product code for Mammotome revolve Dual Vacuum Assist Biopsy System?

The FDA product code for Mammotome revolve Dual Vacuum Assist Biopsy System is KNW.

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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 K170803HydroMARK Breast Biopsy Site Markers K203097HydroMARK Breast Biopsy Site Markers K202012Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System 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

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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