Lithoclast Ek-386B
by E.M.S. Electro Medical Systems S.A. 2 variants
Lithoclast Ek-386B (M0068402050) is a Class II device made by E.M.S. Electro Medical Systems S.A., cleared under FDA 510(k) K173234 on 10 Jan 2018 and listed in FDA GUDID since 12 Mar 2018 (UDI-DI 07613353125806), 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 | Number07613353125806 | Date12 Mar 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK173234 | Date10 Jan 2018 | StatusActive |
Official records
- AccessGUDID record 07613353125806
- FDA 510(k) database K173234
Across registries
- FDA 510(k) K173234 decided 10 Jan 2018 Active
- FDA GUDID UDI-DI 07613353125806 listed 12 Mar 2018 Listed
Timeline
- Cleared FDA 510(k) K173234
- Listed FDA GUDID 07613353125806
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Lithoclast
- Generic name
- Pneumatic/ultrasonic lithotripsy system
- Model / Ref / Catalog
- EK-386B, M0068402050
- Primary DI / UDI-DI
- 07613353125806
- 510(k) Number
- FDA product code
- FFK
- GMDN term
- Pneumatic/ultrasonic lithotripsy system
- Device class
- Class II
- Regulation number
- 876.4480
- GUDID distribution status
- In Commercial Distribution