Device product
KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
Z-1055-2025
Product summary
- Event
- Event 95975
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1510 units
- Official record key
device-enforcement:Z-1055-2025
Official wording
Reason: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Code information: All Lots/UDI: 04048551231333
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.