Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
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- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- Diagnostic DevicesCFR Sub-Part
- GCILaryngoscope, Endoscope2Product Code
- GCJLaparoscope, General & Plastic Surgery2Product Code
- MFJDevice, Endoscopic Suturing2Product Code
- EPYSpeculum, Ent1Product Code
- NAYSystem, Surgical, Computer Controlled Instrument2Product Code
- NEQDevice, Telemedicine, Robotic2Product Code
- PDTBurn Resuscitation Decision Support Software2Product Code
- FDPApparatus, Pneumoperitoneum, Automatic2Product Code
- GCGPeritoneoscope2Product Code
- GCHMediastinoscope, Diagnostic2Product Code
- OTJLaparoscopic Single Port Access Device2Product Code
- OWNConfocal Optical Imaging2Product Code
- QGYMobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera2Product Code
- NQQSystem, Imaging, Optical Coherence Tomography (Oct)2Product Code
- K210458OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System2Cleared 510(K)
- K203578OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System2Cleared 510(K)
- K201552ApolloVue S100 Image System2Cleared 510(K)
- K192922Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter2Cleared 510(K)
- K191117NvisionVLE Low-profile Optical Probe2Cleared 510(K)
- K183320Ilumien Optis, Optis Integrated, Optis Mobile2Cleared 510(K)
- K190404OTIS Optical Coherence Tomography SYstem2Cleared 510(K)
- K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System2Cleared 510(K)
- K182261NvisionVLE Imaging System, NvisionVLE Optical Probe2Cleared 510(K)
- K171560OTIS Optical Coherence Tomography System2Cleared 510(K)
- Show All 32 Submissions
- POYPost Breast Biopsy Hemostatic Breast Compression Device2Product Code
- FXESpeculum, Non-Illuminated1Product Code
- FXFSpeculum, Illuminated1Product Code
- FXGSpecula Accessories1Product Code
- JYKHolder, Ear Speculum1Product Code
- KAGHolder, Speculum, Ent1Product Code
- QSMSystem, Surgical, Computer Controlled Instrument, Remanufactured2Product Code
- General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- MiscellaneousMiscellaneous
- Neurological Surgical DevicesCFR Sub-Part
- Physical Medicine Therapeutic DevicesCFR Sub-Part
- Prosthetic DevicesCFR Sub-Part
- Surgical DevicesCFR Sub-Part
- Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K182616
- 510(k) Type
- Traditional
- Applicant
- NinePoint Medical, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent - With Limitations
- Decision Date
- 11/2/2018
- Days to Decision
- 42 days
- Submission Type
- Summary