Stonetome Stone Removal Device— 510(k) K191789

Unknown

Boston Scientific Corporation

FDA 510(k) clearance K191789 for Stonetome Stone Removal Device, Unknown on 2019-07-25. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code LQR
Device class: Class 2
Regulation: 21 CFR 876.5010
Advisory panel: Gastroenterology, Urology
Date received: 2019-07-03
Decision date: 2019-07-25
Decision: Unknown
Clearance type: Special
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LQR

K253056 — Disposable Stone Extraction Basket2026-04-03
K243807 — Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P2025-03-18
K243471 — Extraction Basket2024-12-16
K240192 — Single-use Extraction Baskets2024-10-15
K230598 — Stone Extraction Baskets2023-09-12

More clearances from Boston Scientific Corporation

K262151 — SpaceOAR Flex System2026-09-11
K261153 — LithoVue Elite Digital Flexible Ureteroscope System2026-08-26
K261915 — Navigator Flex Ureteral Access Sheath Set2026-08-04
K261488 — OBSIDIO Conformable Embolic2026-07-24
K262165 — FARADRIVE Steerable Sheath (M004PF21M402)2026-07-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.