Not Cleared Direct

DEN230082 - Stone Clear (SC-LP9-01) (FDA 510(k) Clearance)

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

DEN230082 · Sonomotion, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
328d
Days
Class 2
Risk

DEN230082 is an FDA 510(k) submission (not cleared) for the Stone Clear (SC-LP9-01). Classified as Ultrasonic Urinary Stone Propulsion Device (product code QNA), Class II - Special Controls.

Submitted by Sonomotion, Inc. (San Mateo, US). The FDA issued a Not Cleared (DENG) decision on October 30, 2024 after a review of 328 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4690 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 328 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Sonomotion, Inc. devices

Submission Details

510(k) Number DEN230082 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 07, 2023
Decision Date October 30, 2024
Days to Decision 328 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
198d slower than avg
Panel avg: 130d · This submission: 328d
Pathway characteristics

Device Classification

Product Code QNA Ultrasonic Urinary Stone Propulsion Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4690
Definition An Ultrasonic Urinary Stone Propulsion Device Visualizes Urinary Stones In The Upper Urinary Tract And Delivers Focused Acoustic Pulses To Reposition The Stones To Facilitate Their Passage.
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.