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BOA VISION
Richard Wolf GmbH · Model 7355071 · UDI-DI 04055207054840
10
510(k) clearances
6,637
Adverse events (7 deaths)
27
Recalls
119
Facilities
Description
SENSOR-URETERORENOSCOPE 8.7FR WL 680MM flexible, working channel 3.6 Fr, slanted distal tip Ø 6.6 Fr, TL 980 mm, deflection +270°/-270°, two function buttons, control lever to distal – downward DEF, for connection to ENDOCAM Logic, LED-illumination, distal Sensor, Fixfocus
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
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Get your free API keyRead the docsData 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.