Device product
KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Z-1057-2025
Product summary
- Event
- Event 95975
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 59 units
- Official record key
device-enforcement:Z-1057-2025
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: 04048551231210
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.