Endosee ESDX5
Endosee ESDX5 is a Class II device made by CooperSurgical, Inc., cleared under FDA 510(k) K132384 on 2 Jul 2014 and listed in FDA GUDID since 29 Aug 2016 (UDI-DI 60888937013780), 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 | Number60888937013780 | Date29 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK132384 | Date2 Jul 2014 | StatusActive |
Official records
- AccessGUDID record 60888937013780
- FDA 510(k) database K132384
Across registries
- FDA 510(k) K132384 decided 2 Jul 2014 Active
- FDA GUDID UDI-DI 60888937013780 listed 29 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K132384
- Listed FDA GUDID 60888937013780
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Endosee
- Generic name
- Flexible fibreoptic hysteroscope
- Model / reference
- ESDX5
- Primary DI / UDI-DI
- 60888937013780
- 510(k) Number
- FDA product code
- HIH
- GMDN term
- Flexible fibreoptic hysteroscope
- Device class
- Class II
- Regulation number
- 884.1690
- GUDID distribution status
- In Commercial Distribution
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