Clearance Summary
SignalMark Lung Biopsy Site Marker received FDA 510(k) clearance under submission number K180175, sponsored by View Point Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2018-12-07.
- Submission: K180175
- Applicant / Sponsor: View Point Medical, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4750
- Decision date: 2018-12-07
Classification & Regulation
This clearance is catalogued under FDA product code GDW and 21 CFR 878.4750, within the General, Plastic Surgery review panel as a Class II device.