EndoGator Hybrid 4003181
EndoGator Hybrid 4003181 is a Class II device made by Medivators Inc., cleared under FDA 510(k) K102855 on 19 Nov 2010 and listed in FDA GUDID since 29 May 2024 (UDI-DI 00724995224226), 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 | Number00724995224226 | Date29 May 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK102855 | Date19 Nov 2010 | StatusActive |
Official records
- AccessGUDID record 00724995224226
- FDA 510(k) database K102855
Across registries
- FDA 510(k) K102855 decided 19 Nov 2010 Active
- FDA GUDID UDI-DI 00724995224226 listed 29 May 2024 Listed
Timeline
- Cleared FDA 510(k) K102855
- Listed FDA GUDID 00724995224226
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EndoGator Hybrid
- Generic name
- Surgical irrigation tubing set, single-use
- Model / Ref / Catalog
- 4003181
- Description
- EndoGator Tubing Hybrid, Fuji 700, used with the EndoGator Irrigation Pump SMTHD
- Primary DI / UDI-DI
- 00724995224226
- 510(k) Number
- FDA product code
- OCX
- GMDN term
- Surgical irrigation tubing set, single-use
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
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