Clarus Digital Control Module 5190-500
Clarus Digital Control Module 5190-500 is a Class II device made by Clarus Medical, LLC, cleared under FDA 510(k) K223615 on 21 Nov 2023 and listed in FDA GUDID since 19 Feb 2024 (UDI-DI 10810004821016), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10810004821016 | Date19 Feb 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK223615 | Date21 Nov 2023 | StatusActive |
Official records
- AccessGUDID record 10810004821016
- FDA 510(k) database K223615
Across registries
- FDA 510(k) K223615 decided 21 Nov 2023 Active
- FDA GUDID UDI-DI 10810004821016 listed 19 Feb 2024 Listed
Timeline
- Cleared FDA 510(k) K223615
- Listed FDA GUDID 10810004821016
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Clarus Digital Control Module
- Generic name
- Endoscopic video image processing/light source system
- Model / Ref / Catalog
- 5190-500
- Primary DI / UDI-DI
- 10810004821016
- 510(k) Number
- FDA product code
- GWG
- GMDN term
- Endoscopic video image processing/light source system
- Device class
- Class II
- Regulation number
- 882.1480
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Endoscopic video image processing/light source system.