U04
by Siemens Medical Solutions USA, Inc.
510(k) K010942
U04 is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K010942 on 12 Apr 2001, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK010942 | Date12 Apr 2001 | StatusActive |
Official records
- FDA 510(k) database K010942
Recalls
-
- Terminated Z-2341-2012
Siemens has discovered a possible hazard to patients or hospital personnel when tilting the Uroskop Access system starting with serial number 6076. When tilting the table on the Uroskop Access table, the motor may become disconnected and the entire table assembly may fall on the floor.
Timeline
- Cleared FDA 510(k) K010942
- Recall initiated FDA recalls Z-2341-2012
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OWB
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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