Ninepoint Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: NvisionVLE Low-profile Optical Probe, NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System, NvisionVLE Imaging System, NvisionVLE Optical Probe
8
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ninepoint Medical, Inc. General & Plastic Surgery ✕
8 devices
Cleared
Jul 19, 2019
NvisionVLE Low-profile Optical Probe
General & Plastic Surgery
84d
Cleared
Nov 02, 2018
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
General & Plastic Surgery
42d
Cleared
Oct 16, 2018
NvisionVLE Imaging System, NvisionVLE Optical Probe
General & Plastic Surgery
56d
Cleared
Feb 16, 2016
NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon,...
General & Plastic Surgery
76d
Cleared
Feb 06, 2015
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation...
General & Plastic Surgery
44d
Cleared
Apr 25, 2013
NVISION VLE IMAGING SYSTEM
General & Plastic Surgery
405d
Cleared
Jul 25, 2012
NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
General & Plastic Surgery
97d
Cleared
Dec 16, 2011
NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER
General & Plastic Surgery
84d