Device product
KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
Z-1051-2025
Product summary
- Event
- Event 95975
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 Units
- Official record key
device-enforcement:Z-1051-2025
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: 04048551231296
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.