Eea EEA2535
by Covidien LP
Eea EEA2535 is a Class II device made by Covidien LP, cleared under FDA 510(k) K221003 on 30 Sep 2022 (1 earlier submission) and listed in FDA GUDID since 1 Sep 2015 (UDI-DI 10884523004748), 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 | FDA 510(k)SESE | NumberK221003 | Date30 Sep 2022 | StatusActive |
| United States | GUDID listing | Number10884523004748 | Date1 Sep 2015 | StatusListed |
Official records
- AccessGUDID record 10884523004748
- FDA 510(k) database K221003
- FDA 510(k) database K062850
Across registries
- FDA 510(k) K221003 decided 30 Sep 2022 Active
- FDA GUDID UDI-DI 10884523004748 listed 1 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K062850
- Listed FDA GUDID 10884523004748
- Cleared FDA 510(k) K221003
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Eea
- Generic name
- Intraluminal circular stapler, single-use
- Model / reference
- EEA2535
- Primary DI / UDI-DI
- 10884523004748
- FDA product code
- GDW, GAG
- GMDN term
- Intraluminal circular stapler, single-use
- Device class
- Class II
- Regulation number
- 878.4750, 878.4740
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Size
- Length — 25 MillimeterHeight — 3.5 Millimeter