Cleared Special

Stonetome Stone Removal Device

K191789 · Boston Scientific Corporation · Gastroenterology & Urology
Jul 2019
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K191789 is an FDA 510(k) clearance for the Stonetome Stone Removal Device, a Dislodger, Stone, Biliary (Class II — Special Controls, product code LQR), submitted by Boston Scientific Corporation (Marborough, US). The FDA issued a Cleared decision on July 25, 2019, 22 days after receiving the submission on July 3, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.

Submission Details

510(k) Number K191789 FDA.gov
FDA Decision Cleared SESK
Date Received July 03, 2019
Decision Date July 25, 2019
Days to Decision 22 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code LQR — Dislodger, Stone, Biliary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5010

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