Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Ninepoint Medical, Inc.

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories1
Latest FDA decision2019-07-19
TypeNumberDevice NameCodeDateActions
510(k) K191117 NvisionVLE Low-profile Optical ProbeNQQ2019-07-19 View
510(k) K182616 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNQQ2018-11-02 View
510(k) K182261 NvisionVLE Imaging System, NvisionVLE Optical ProbeNQQ2018-10-16 View
510(k) K153479 NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation SystemNQQ2016-02-16 View
↑