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COBRA VISION

Richard Wolf GmbH · Model 7356076 · UDI-DI 04055207054871

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

Description

SENSOR-URETERORENOSCOPE 9.9FR WL 680MM flexible, working channel 1: 3.6 Fr, working channel 2: 2.4 Fr, double-slanted distal tip Ø 5.2 Fr, TL 980 mm, deflection +270°/-270°, laser shifter for fixing and guiding the laser fiber, locking lever for distal tip, control lever to distal, upward DEF, two function buttons, for connection to ENDOCAM Logic, LED illumination, distal sensor, Fixfocus

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.