Esop®
by Fournitures Hospitalieres Industrie 76 variants
Esop® is a Class II device made by Fournitures Hospitalieres Industrie, cleared under FDA 510(k) K961388 on 3 Apr 1997 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 03661489450426), active as of 21 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 | Number03661489450426 | Date24 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK961388 | Date3 Apr 1997 | StatusActive |
Official records
- AccessGUDID record 03661489450426
- FDA 510(k) database K961388
Across registries
- FDA 510(k) K961388 decided 3 Apr 1997 Active
- FDA GUDID UDI-DI 03661489450426 listed 24 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K961388
- Listed FDA GUDID 03661489450426
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Acetabular shell
- Model / reference
- 245042 - ACETABULAR LINER/PE, Ø22, 22 / Ø56
- Primary DI / UDI-DI
- 03661489450426
- 510(k) Number
- FDA product code
- MEH
- GMDN term
- Acetabular shell
- Device class
- Class II
- Regulation number
- 888.3353
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under Acetabular shell.