Diego Elite 70338011
Diego Elite 70338011 is a Class II device made by Gyrus Acmi, Inc., cleared under FDA 510(k) K020594 on 8 Mar 2002 and listed in FDA GUDID since 12 Oct 2016 (UDI-DI 00821925026155), 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 | Number00821925026155 | Date12 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK020594 | Date8 Mar 2002 | StatusActive |
Official records
- AccessGUDID record 00821925026155
- FDA 510(k) database K020594
Across registries
- FDA 510(k) K020594 decided 8 Mar 2002 Active
- FDA GUDID UDI-DI 00821925026155 listed 12 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K020594
- Listed FDA GUDID 00821925026155
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Diego Elite
- Generic name
- Foot-switch, electrical
- Model / reference
- 70338011
- Primary DI / UDI-DI
- 00821925026155
- 510(k) Number
- FDA product code
- ERL
- GMDN term
- Foot-switch, electrical
- Device class
- Class II
- Regulation number
- 874.4250
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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