Ninepoint Medical Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
8
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1781-2018Class IINvisionVLE¿ Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: April 11, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K191117NvisionVLE Low-profile Optical ProbeJuly 19, 2019
K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNovember 2, 2018
K182261NvisionVLE Imaging System, NvisionVLE Optical ProbeOctober 16, 2018
K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm bFebruary 16, 2016
K143678NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation AccessoryFebruary 6, 2015
K120800NVISION VLE IMAGING SYSTEMApril 25, 2013
K121195NVISION VLE IMAGING SYSTEM NVISION VLE CATHETERJuly 25, 2012
K112770NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETERDecember 16, 2011