Modularis Variostar 01157200
Modularis Variostar 01157200 is a Class II device made by Siemens Healthcare GmbH, cleared under FDA 510(k) K070799 on 1 Nov 2007 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04056869008974), active as of 12 Nov 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04056869008974 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK070799 | Date1 Nov 2007 | StatusActive |
Official records
- AccessGUDID record 04056869008974
- FDA 510(k) database K070799
Across registries
- FDA 510(k) K070799 decided 1 Nov 2007 Active
- FDA GUDID UDI-DI 04056869008974 listed 24 Sep 2016 Listed
Recalls
-
- Terminated Z-0265-2016
Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.
Timeline
- Cleared FDA 510(k) K070799
- Recall initiated FDA recalls Z-0265-2016
- Listed FDA GUDID 04056869008974
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Modularis Variostar
- Generic name
- Electromechanical lithotripsy system, extracorporeal
- Model / reference
- 01157200
- Primary DI / UDI-DI
- 04056869008974
- 510(k) Number
- FDA product code
- LNS
- GMDN term
- Electromechanical lithotripsy system, extracorporeal
- Device class
- Class II
- Regulation number
- 876.5990
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code LNS (Lithotriptor, extracorporeal shock-wave,urological).
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- TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE) by Direx Systems Corp.
- PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000 by United Medical Systems, Inc.
- DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER by E.S.W.L. Products, Inc.