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FDA 510(k)

SignalMark Lung Biopsy Site Marker

K-Number: K180175 · 2018-12-07

ApplicantView Point Medical, Inc.
Decision Date2018-12-07
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SignalMark Lung Biopsy Site Marker is a medical device manufactured by View Point Medical, Inc.. It received FDA 510(k) clearance on 2018-12-07 under approval number K180175. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SignalMark Lung Biopsy Site Marker?

SignalMark Lung Biopsy Site Marker is a medical device that received FDA 510(k) clearance on 2018-12-07. It is manufactured by View Point Medical, Inc.. The 510(k) number is K180175.

When was SignalMark Lung Biopsy Site Marker approved by the FDA?

SignalMark Lung Biopsy Site Marker received FDA 510(k) clearance on 2018-12-07, under approval number K180175.

What company makes SignalMark Lung Biopsy Site Marker?

SignalMark Lung Biopsy Site Marker is manufactured by View Point Medical, Inc..

What is the FDA product code for SignalMark Lung Biopsy Site Marker?

The FDA product code for SignalMark Lung Biopsy Site Marker is GDW.

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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.

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