MUSE System
510(k) K143634
MUSE System is a Class II device made by Medigus, Ltd., cleared under FDA 510(k) K143634 on 20 Jan 2015, active as of 11 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 | NumberK143634 | Date20 Jan 2015 | StatusActive |
Official records
- FDA 510(k) database K143634
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ODE
- FDA applicant
- Medigus , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
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