GeniFlow 700-000-005
by Genicon
GeniFlow 700-000-005 is a Class II device made by Genicon, cleared under FDA 510(k) K041967 on 12 Nov 2004 and listed in FDA GUDID since 5 May 2017 (UDI-DI 00877972004653), 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 | Number00877972004653 | Date5 May 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK041967 | Date12 Nov 2004 | StatusActive |
Official records
- AccessGUDID record 00877972004653
- FDA 510(k) database K041967
Across registries
- FDA 510(k) K041967 decided 12 Nov 2004 Active
- FDA GUDID UDI-DI 00877972004653 listed 5 May 2017 Listed
Timeline
- Cleared FDA 510(k) K041967
- Listed FDA GUDID 00877972004653
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- GeniFlow
- Generic name
- Surgical irrigation/aspiration tubing set
- Model / reference
- 700-000-005
- Primary DI / UDI-DI
- 00877972004653
- 510(k) Number
- FDA product code
- GCJ
- GMDN term
- Surgical irrigation/aspiration tubing set
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
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