Identity
- Trade Name
- Clarus Digital Control Module FDA UDI
- Generic Name
- Endoscopic video image processing/light source system FDA UDI
- Device Name
- Clarus Digital Control Module FDA UDI
- Model / Reference
- 5190-500 FDA UDI
- Description
- Clarus Digital Control Module FDA UDI
Identifiers
- Catalog Number
- 5190-500 FDA UDI
- Primary DI / UDI-DI
- 10810004821016 FDA UDI
- 510(k) Number
- K223615 FDA UDI
- FDA Product Code
- GWG FDA UDI
- GMDN Term
- Endoscopic video image processing/light source system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1480 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
No
FDA UDI
Category: Endoscopic video image processing/light source system
Clarus Digital Control Module by Clarus Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K223615 also covers:
- Clarus Digital ChannelScope Endoscope, 11.0cm — CLARUS MEDICAL, LLC
- Clarus Digital ChannelScope Endoscope, 13.0cm — CLARUS MEDICAL, LLC
- Clarus Digital ChannelScope Endoscope, 21.6cm — CLARUS MEDICAL, LLC
- Clarus Digital ChannelScope Endoscope, 21.6cm, 3.5mm OD — CLARUS MEDICAL, LLC
- Clarus Digital ClarusScope Endoscope — CLARUS MEDICAL, LLC
- Clarus Digital NeuroPEN Endoscope, 15.5cm — CLARUS MEDICAL, LLC
- Clarus Digital NeuroPEN Endoscope, 19.0cm — CLARUS MEDICAL, LLC
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
- Clarus Medical, Llc
Sources (1)
- FDA UDI 360c4eb5-404c-48a9-a9f4-56a369648f5d 36 fields · synced Jun 6, 2026