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E-LINE

Richard Wolf GmbH · Model 8702523 · UDI-DI 04055207020005

FGB
10
510(k) clearances
6,637
Adverse events (7 deaths)
27
Recalls
119
Facilities

Description

URETERORENOSCOPE 5° 6/7.5FR WL 315MM semi-rigid, with lateral ocular lens, working channel 1x4 (2x2.2)Fr, atraumatic distal tip, TL 484mm, fiber image carrier

Recalls

DateFirmReason
2024-12-19Karl Storz EndoscopyScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-12-19Karl Storz EndoscopyScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-12-19Karl Storz EndoscopyScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-12-19Karl Storz EndoscopyScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-12-19Karl Storz EndoscopyScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-12-19Karl Storz EndoscopyScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-12-19Karl Storz EndoscopyScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-12-19Karl Storz EndoscopyScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-12-19Karl Storz EndoscopyScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-12-19Karl Storz EndoscopyScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.