NvisionVLE Marking Probe 17mm Clinical
The NvisionVLE Marking Probe is a single-use sterile probe passed through an endoscope’s working channel. Its balloon is inflated by the NvisionVLE Inflation System to facilitate probe…
The NvisionVLE Marking Probe is a single-use sterile probe passed through an endoscope’s working channel. Its balloon is inflated by the NvisionVLE Inflation System to facilitate probe placement.
The imaging system uses optical coherence tomography to create real-time cross-sectional views of tissue. Its marking function uses an integrated laser to make temporary visible marks on tissue regions of interest identified on the image.
Probe Role
A probe lock accessory helps stabilize the marking probe during laser marking.
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Shenzhen Vivolight Medical Device&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Ninepoint Medical, Inc., United States |
|---|---|
| FDA product code | NQQ |
| Device type | System, Imaging, Optical Coherence Tomography (Oct) |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1560 |
| 510(k) | K153479 |
| Record published | 2016-09-22 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature -28 to 50 °C; Handling environment humidity 15 to 85 % RH |
| Sizes | Outer diameter 17 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 95301-M-17C | Outer Diameter 17 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Optis™ | St. Jude Medical | 13 |
| Optis™ | Lightlab Imaging, Inc. | 11 |
| Luminscan(TM) Disposable Imaging Kit | Micro-Tech (Nanjing) Co., Ltd. | 9 |
| Ilumien™ | Lightlab Imaging, Inc. | 6 |
| Cornaris Intravascular Imaging System | Shenzhen Vivolight Medical Device&Technology Co., Ltd. | 2 |
| VivoSight | Michelson Diagnostics Ltd | 2 |
| AptiVue™ | Lightlab Imaging, Inc. | 2 |
| Pantheris | Avinger, Inc. | 2 |
| NvisionVLE Imaging Console | Ninepoint Medical, Inc. | 1 |
| NvisionVLE Imaging Console Refurbished | Ninepoint Medical, Inc. | 1 |
| NvisionVLE Marking Probe 17mm | Ninepoint Medical, Inc. | 1 |
| NvisionVLE Low Profile Imaging Probe, 20mm Working Distance | Ninepoint Medical, Inc. | 1 |
Showing 12 of 56. All products under System, Imaging, Optical Coherence Tomography (Oct)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191117 | 2019-07-19 |
| K182616 | 2018-11-02 |
| K182261 | 2018-10-16 |
| K153479 | 2016-02-16 |
| K143678 | 2015-02-06 |
| K120800 | 2013-04-25 |
| K121195 | 2012-07-25 |
| K112770 | 2011-12-16 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-04-11 | Class II | Process control | Distal tips of the probes may detach from the probe shaft during use. | 152 | 2018-08-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.