Clarus Endoscopy Pump 5169-100
Clarus Endoscopy Pump 5169-100 is a Class II device made by Clarus Medical, LLC, cleared under FDA 510(k) K912447 on 27 Sep 1991 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI B06751691000), 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 | NumberB06751691000 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK912447 | Date27 Sep 1991 | StatusActive |
Official records
- FDA 510(k) database K912447
Across registries
- FDA 510(k) K912447 decided 27 Sep 1991 Active
- FDA GUDID UDI-DI B06751691000 listed 22 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K912447
- Listed FDA GUDID B06751691000
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Clarus Endoscopy Pump
- Generic name
- Endoscopic irrigation/aspiration pump
- Model / Ref / Catalog
- 5169-100
- Primary DI / UDI-DI
- B06751691000
- 510(k) Number
- FDA product code
- FET
- GMDN term
- Endoscopic irrigation/aspiration pump
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
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