Ninepoint Medical Inc.
FDA Regulatory Profile
Ninepoint Medical Inc. appears in FDA public data with 1 recall, 8 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1781-2018, Class II) was initiated on April 11, 2018. Its most recent 510(k) clearance was granted on July 19, 2019.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 8
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1781-2018 | Class II | NvisionVLE¿ Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: | April 11, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K191117 | NvisionVLE Low-profile Optical Probe | July 19, 2019 |
| K182616 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System | November 2, 2018 |
| K182261 | NvisionVLE Imaging System, NvisionVLE Optical Probe | October 16, 2018 |
| K153479 | NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm b | February 16, 2016 |
| K143678 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory | February 6, 2015 |
| K120800 | NVISION VLE IMAGING SYSTEM | April 25, 2013 |
| K121195 | NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER | July 25, 2012 |
| K112770 | NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER | December 16, 2011 |