Identity
- Trade Name
- ColonPRO™ 4.0 FDA UDI
- Generic Name
- Endoscopic video image interpretive software FDA UDI
- Model / Reference
- 4.0.1-S FDA UDI
Identifiers
- Catalog Number
- CPRO401S-US FDA UDI
- Primary DI / UDI-DI
- 08055060110376 FDA UDI
- 510(k) Number
- K241887 FDA UDI
- FDA Product Code
- QNP FDA UDI
- GMDN Term
- Endoscopic video image interpretive software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1520 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscopic video image interpretive software
ColonPRO™ 4.0 by Linkverse Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic video image interpretive software.
- CADDIE — ODIN MEDICAL LIMITED · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- ColonPRO™ 4.0 — LINKVERSE SRL · Class II
- ColonPRO™ 4.0 — LINKVERSE SRL · Class II
Cleared under the same submission
K241887 also covers:
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 |
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Manufacturer
- Manufacturer
- Linkverse Srl
Sources (1)
- FDA UDI 85c58049-c437-45e8-bdf6-badd453c093f 34 fields · synced Jun 1, 2026