Epiguard
by Episafe Medical Devices, Ltd. 510(k)
Active
510(k) K050188
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK050188 | Date27 Apr 2005 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JXL
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5070
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent