Modulith® Slx-F2
Modulith® Slx-F2 is a Class II device made by Storz Medical AG, cleared under FDA 510(k) K072788 on 26 Dec 2007 (2 earlier submissions) and listed in FDA GUDID since 24 Aug 2016 (UDI-DI 07630039100230), 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 | Number07630039100230 | Date24 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK072788 | Date26 Dec 2007 | StatusActive |
Official records
- AccessGUDID record 07630039100230
- FDA 510(k) database K072788
- FDA 510(k) database K070579
- FDA 510(k) database K004037
Across registries
- FDA 510(k) K072788 decided 26 Dec 2007 Active
- FDA GUDID UDI-DI 07630039100230 listed 24 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K004037
- Cleared FDA 510(k) K070579
- Cleared FDA 510(k) K072788
- Listed FDA GUDID 07630039100230
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Modulith®
- Generic name
- Electromechanical lithotripsy system, extracorporeal
- Model / reference
- SLX-F2
- Primary DI / UDI-DI
- 07630039100230
- FDA product code
- LNS, JAA
- GMDN term
- Electromechanical lithotripsy system, extracorporeal
- Device class
- Class II
- Regulation number
- 876.5990, 892.1650
- GUDID distribution status
- In Commercial Distribution
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