LithoVue Elite Digital Flexible Ureteroscope System— 510(k) K261153
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K261153 for LithoVue Elite Digital Flexible Ureteroscope System, Substantially Equivalent on 2026-08-26. Applicant: Boston Scientific Corporation. Device class: 2.
Summary
Boston Scientific's LithoVue Elite Digital Flexible Ureteroscope System is filed under product code FGB, flexible or rigid ureteroscopes and accessories. The record gives no model numbers.
Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel. It was a Traditional 510(k).
Boston Scientific filed from Marlborough, Massachusetts. The substantially equivalent decision came 140 calendar days after receipt (April 8 to August 26, 2026).
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Product code FGB
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
Recent devices under product code FGB
view all- K261447 — CVAC® Aspiration System
- K262488 — Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)
- K262552 — Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)
- K253505 — Zamenix P
- K260516 — BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
More clearances from Boston Scientific Corporation
view allAdverse events under product code FGB
product code FGB- Death
- 6
- Injury
- 552
- Malfunction
- 3,922
- Other
- 1
- Total
- 4,481
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.