Identity
- Trade Name
- NvisionVLE Marking Console FDA UDI
- Generic Name
- Endoscopic optical coherence tomography system FDA UDI
- Model / Reference
- 94301-M FDA UDI
Identifiers
- Catalog Number
- 94301-M FDA UDI
- Primary DI / UDI-DI
- 00859591006102 FDA UDI
- 510(k) Number
- K153479 FDA UDI
- FDA Product Code
- NQQ FDA UDI
- GMDN Term
- Endoscopic optical coherence tomography system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic optical coherence tomography system
NvisionVLE Marking Console by Ninepoint Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic optical coherence tomography system.
- NvisionVLE Imaging System with Targeted Biopsy - Upgrade — NINEPOINT MEDICAL, INC. · Class II
- NvisionVLE Imaging Console — NINEPOINT MEDICAL, INC. · Class II
- NvisionVLE Marking Console with IRIS, Upgraded, Refurbished — NINEPOINT MEDICAL, INC. · Class II
- NvisionVLE Marking Console with IRIS — NINEPOINT MEDICAL, INC. · Class II
- NvisionVLE Imaging Console Refurbished — NINEPOINT MEDICAL, INC. · Class II
- NvisionVLE Marking Console with IRIS, Upgraded — NINEPOINT MEDICAL, INC. · Class II
- NvisionVLE Marking Upgrade Refurbished — NINEPOINT MEDICAL, INC. · Class II
- NvisionVLE Marking Console with IRIS, Refurbished — NINEPOINT MEDICAL, INC. · Class II
Cleared under the same submission
K153479 also covers:
- NvisionVLE Imaging System with Targeted Biopsy - Upgrade — NINEPOINT MEDICAL, INC.
- NvisionVLE Marking Console Refurbished — NINEPOINT MEDICAL, INC.
- NvisionVLE Marking Probe 14mm — NINEPOINT MEDICAL, INC.
- NvisionVLE Marking Probe 14mm Clinical — NINEPOINT MEDICAL, INC.
- NvisionVLE Marking Probe 17mm — NINEPOINT MEDICAL, INC.
- NvisionVLE Marking Probe 17mm Clinical — NINEPOINT MEDICAL, INC.
- NvisionVLE Marking Probe 20mm — NINEPOINT MEDICAL, INC.
- NvisionVLE Marking Probe 20mm Clinical — NINEPOINT MEDICAL, INC.
- NvisionVLE Marking Upgrade Refurbished — NINEPOINT MEDICAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ninepoint Medical, Inc.
Sources (1)
- FDA UDI c98396bb-b589-4bc4-bedb-0b1a8625f015 36 fields · synced Jun 8, 2026