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FDA 510(k)

SignalMark Breast Marker

K-Number: K190689 · 2019-08-14

ApplicantView Point Medical, Inc.
Decision Date2019-08-14
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SignalMark Breast Marker is a medical device manufactured by View Point Medical, Inc.. It received FDA 510(k) clearance on 2019-08-14 under approval number K190689. 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 SignalMark Breast Marker?

SignalMark Breast Marker is a medical device that received FDA 510(k) clearance on 2019-08-14. It is manufactured by View Point Medical, Inc.. The 510(k) number is K190689.

When was SignalMark Breast Marker approved by the FDA?

SignalMark Breast Marker received FDA 510(k) clearance on 2019-08-14, under approval number K190689.

What company makes SignalMark Breast Marker?

SignalMark Breast Marker is manufactured by View Point Medical, Inc..

What is the FDA product code for SignalMark Breast Marker?

The FDA product code for SignalMark Breast Marker is NEU.

Related Clinical Trials

NCT04968990 Treatment of Newly Diagnosed Patient's With Wilm's Tumor Requiring Abdominal Radiation Delivered With Proton Beam Irradiation RECRUITING NCT05547347 Safety, Ultrasound Conspicuity, and Migration of Twinkling Markers in Patients With Locally Advanced Breast Cancer SUSPENDED

Other Devices by View Point Medical, Inc.

K180175SignalMark Lung Biopsy Site Marker

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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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