Modularis Variostar
by Siemens Medical Solutions USA, Inc.
510(k) K070799
Modularis Variostar is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K070799 on 1 Nov 2007, active as of 10 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK070799 | Date1 Nov 2007 | StatusActive |
Official records
- FDA 510(k) database K070799
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
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LNS
- Device class
- Class II
- Regulation
- 21 CFR Part 876.5990
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K070799
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Modularis Variostar 01157200 | 01157200 | 04056869008974 | — | On the market |
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