LithoVue Elite Digital Flexible Ureteroscope System: FDA status

Approved Approved Dec 12, 2023. Indication: visualization of organs cavities and canals in the urinary tract during kidney stone procedures.

Regulatory history

• Dec 12, 2023: 510(k) clearance. A second 510k clearance K233645 for the LithoVue Elite ureteroscope system was granted on December 12 2023 per Boston Scientific FDA filings. accessdata.fda.gov

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