Cleared Special

K191789 - Stonetome Stone Removal Device (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K191789 · Boston Scientific Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
22d
Days
Class 2
Risk

K191789 is an FDA 510(k) clearance for the Stonetome Stone Removal Device. Classified as Dislodger, Stone, Biliary (product code LQR), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on July 25, 2019 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K191789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 130d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LQR Dislodger, Stone, Biliary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - LQR Dislodger, Stone, Biliary

All 37
Devices cleared under the same product code (LQR) and FDA review panel - the closest regulatory comparables to K191789.
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Extraction Basket
K243471 · Micro-Tech (Nanjing) Co., Ltd. · Dec 2024
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K240192 · Scivita Medical Technology Co., Ltd. · Oct 2024
Stone Extraction Baskets
K230598 · Jiangsu Vedkang Medical Science and Technology Co., Ltd. · Sep 2023
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K203322 · Boston Scientific Corporation · May 2021