Home / 510(k) Clearances / K241598

510(k) K241598

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) by Boston Scientific Corporation — Product Code FGB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2024
Date Received
June 4, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ureteroscope And Accessories, Flexible/Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To perform various diagnostic and therapeutic procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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Other clearances for product code FGB

  • K260013 — CVAC Image Processor (March 6, 2026)
  • K252468 — Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible (December 16, 2025)
  • K251951 — Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, (December 16, 2025)
  • K253411 — Miniature Telescope for Urology (27033AA) (November 18, 2025)
  • K250917 — Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: S (October 31, 2025)
  • K252806 — Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G- (October 3, 2025)
  • K252703 — LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure (September 24, 2025)
  • K250049 — Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscop (August 26, 2025)
  • K243550 — KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) (June 6, 2025)
  • K242699 — Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Uretero (May 28, 2025)