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FDA 510(k)

HydroMARK Breast Biopsy Site Markers

K-Number: K170803 · 2017-06-15

ApplicantDevicor Medical Products, Inc.
Decision Date2017-06-15
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HydroMARK Breast Biopsy Site Markers is a medical device manufactured by Devicor Medical Products, Inc.. It received FDA 510(k) clearance on 2017-06-15 under approval number K170803. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HydroMARK Breast Biopsy Site Markers?

HydroMARK Breast Biopsy Site Markers is a medical device that received FDA 510(k) clearance on 2017-06-15. It is manufactured by Devicor Medical Products, Inc.. The 510(k) number is K170803.

When was HydroMARK Breast Biopsy Site Markers approved by the FDA?

HydroMARK Breast Biopsy Site Markers received FDA 510(k) clearance on 2017-06-15, under approval number K170803.

What company makes HydroMARK Breast Biopsy Site Markers?

HydroMARK Breast Biopsy Site Markers is manufactured by Devicor Medical Products, Inc..

What is the FDA product code for HydroMARK Breast Biopsy Site Markers?

The FDA product code for HydroMARK Breast Biopsy Site Markers is NEU.

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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 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: NEU)

K152510UltraCor Twirl Breast Tissue MarkerBard Peripheral Vascular, Inc. K161021HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc. K171767Cianna Medical SAVI Scout Reflector and SAVI Scout SystemCianna Medical, Inc. K170026Radiopaque Tissue MarkerViscus Biologics, LLC K170905Star Tissue MarkerScion Medical Technologies, LLC K182082Tumark for Eviva, Tumark for BreveraSomatex Medical Technologies GmbH

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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