Lithoclast Fr-311
by E.M.S. Electro Medical Systems S.A.
Lithoclast Fr-311 (M0068403470) is a Class II device made by E.M.S. Electro Medical Systems S.A., cleared under FDA 510(k) K182490 on 9 Oct 2018 (3 earlier submissions) and listed in FDA GUDID since 12 Mar 2018 (UDI-DI 07613353123758), 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 | FDA 510(k)SESE | NumberK182490 | Date9 Oct 2018 | StatusActive |
| United States | GUDID listing | Number07613353123758 | Date12 Mar 2018 | StatusListed |
Official records
- AccessGUDID record 07613353123758
- FDA 510(k) database K182490
- FDA 510(k) database K181997
- FDA 510(k) database K181364
- FDA 510(k) database K173234
Across registries
- FDA 510(k) K182490 decided 9 Oct 2018 Active
- FDA GUDID UDI-DI 07613353123758 listed 12 Mar 2018 Listed
Timeline
- Cleared FDA 510(k) K173234
- Listed FDA GUDID 07613353123758
- Cleared FDA 510(k) K181364
- Cleared FDA 510(k) K181997
- Cleared FDA 510(k) K182490
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Lithoclast
- Generic name
- Ultrasonic lithotripsy system probe, single-use
- Model / Ref / Catalog
- FR-311, M0068403470
- Primary DI / UDI-DI
- 07613353123758
- FDA product code
- FEO, FFK
- GMDN term
- Ultrasonic lithotripsy system probe, single-use
- Device class
- Class II
- Regulation number
- 876.4480
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 425 MillimeterOuter Diameter — 1.1 Millimeter