Company ยท US
Ninepoint Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2019. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 9 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 19, 2019 | K191117 | NvisionVLE Low-profile Optical Probe Ninepoint Medical, Inc. | NQQ |
| Nov 2, 2018 | K182616 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System Ninepoint Medical, Inc. | NQQ |
| Oct 16, 2018 | K182261 | NvisionVLE Imaging System, NvisionVLE Optical Probe Ninepoint Medical, Inc. | NQQ |
| Feb 16, 2016 | K153479 | NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Ma Ninepoint Medical, Inc. | NQQ |
| Feb 6, 2015 | K143678 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory Ninepoint Medical, Inc. | NQQ |
| Apr 25, 2013 | K120800 | NVISION VLE IMAGING SYSTEM Ninepoint Medical, Inc. | NQQ |
| Jul 25, 2012 | K121195 | NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER Ninepoint Medical, Inc. | NQQ |
| Dec 16, 2011 | K112770 | NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER Ninepoint Medical, Inc. | NQQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2018 | Ninepoint Medical Inc. NvisionVLE Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196), (01)00859591006188(17)180731(10)005251), (01)00859591006188 Terminated |
NQQ | K143678 |