Clearance Summary
NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System received FDA 510(k) clearance under submission number K153479, sponsored by Ninepoint Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2016-02-16.
- Submission: K153479
- Applicant / Sponsor: Ninepoint Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 2016-02-16
Classification & Regulation
This clearance is catalogued under FDA product code NQQ and 21 CFR 892.1560, within the Radiology review panel as a Class II device.