LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope -– Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Reverse (without pressure monitoring) (M0067941500)

510(k) K241598

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 25 Oct 2026

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK241598	Date1 Jul 2024Cleared	StatusActive

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

1 jurisdiction

United States — FDA 510(k) Active

510(k)

510(k) Number: K241598
FDA Product Code: FGB
Models / Variants: LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000)
LithoVue Elite Single-Use Digital Flexible Ureteroscope -– Reverse (with pressure monitoring) (M0067940500)
LithoVue Elite Single-Use Digital Flexible Ureteroscope – Standard (without pressure monitoring) (M0067941000)
LithoVue Elite Single-Use Digital Flexible Ureteroscope – Reverse (without pressure monitoring) (M0067941500)
FDA applicant: Boston Scientific Corporation