FDA 510(k)

SignalMark Lung Biopsy Site Marker

K-Number: K180175 · 2018-12-07

Decision Date2018-12-07

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SignalMark Lung Biopsy Site Marker is the device name listed in this FDA 510(k) record. The listed applicant is View Point Medical, Inc.. It received FDA 510(k) clearance on 2018-12-07 under 510(k) 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. The listed applicant is View Point Medical, Inc.. The 510(k) number is K180175.

When did SignalMark Lung Biopsy Site Marker receive FDA 510(k) clearance?

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

Who is the listed applicant for SignalMark Lung Biopsy Site Marker?

The FDA 510(k) record lists View Point Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing View Point Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.