Cleared Traditional

K221515 - StoneSmart Connect Console

K221515 is the FDA 510(k) clearance for StoneSmart Connect Console by Boston Scientific Corporation. It is a Class 2 Gastroenterology & Urology device (product code FGB) cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K221515 · Boston Scientific Corporation · Gastroenterology & Urology device
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Feb 2023
Decision
253d
Days
Class 2
Risk

K221515 is an FDA 510(k) clearance for the StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureter.... Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on February 2, 2023 after a review of 253 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K221515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2022
Decision Date February 02, 2023
Days to Decision 253 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 130d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FGB Ureteroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition 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).
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 - FGB Ureteroscope And Accessories, Flexible/rigid

All 85
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K221515.
Single-Use Flexible Ureteroscope
K230200 · Hunan Vathin Medical Instrument Co., Ltd. · May 2023
Single-Use Video Flexible Ureterorenoscope System
K221158 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Mar 2023
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101
K223466 · STERIS Corporation · Feb 2023
Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)
K222737 · Shanghai AnQing Medical Instrument Co., Ltd. · Oct 2022
Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)
K220159 · Shanghai AnQing Medical Instrument Co., Ltd. · Aug 2022
Monarch Platform, Urology
K213334 · Auris Health, Inc. · Apr 2022