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Stone Clear (SC-LP9-01)

by Sonomotion, Inc.

De Novo DEN230082

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA De Novo, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN230082 Date30 Oct 2024DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA De Novo Active

Specification

De Novo

De Novo Number
FDA Product Code
QNA
Device Class
Class II
Regulation
21 CFR Part 876.4690
Advisory Committee
Gastroenterology, Urology
FDA Decision
DENG De Novo granted

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Stone Clear (SC-LP9-01) is an Ultrasonic Urinary Stone Propulsion Device, classified as a Class II medical device under FDA regulation number 876.4690. This device is designed to reposition residual stone fragments in the upper urinary tract of adult patients following lithotripsy, facilitating their natural passage when each fragment measures 5 mm or smaller. Its primary function is non-invasive, leveraging ultrasonic energy to aid in the movement of fragmented stones without surgical intervention.

The Stone Clear (SC-LP9-01) is supplied as a reusable device and is intended for use in clinical settings such as gastroenterology and urology. It has received FDA 510(k) clearance under K-number DEN230082, with a direct submission pathway through the Gastroenterology and Urology (GU) advisory committee. No specific sterility or MRI safety information is provided in the available data, though its use is restricted to adult patients with residual stone fragments post-lithotripsy. Storage and handling instructions are not detailed in the regulatory records.

Other devices from Sonomotion, Inc.

Questions

AI-generated answers, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Stone Clear (SC-LP9-01) used for in clinical practice?

    The Stone Clear (SC-LP9-01) is designed to help reposition small residual stone fragments (5 mm or smaller) in the upper urinary tract of adult patients after lithotripsy. It uses ultrasonic energy to non-invasively encourage these fragments to move naturally, avoiding the need for surgical removal.

  • Is the Stone Clear (SC-LP9-01) intended for single-use or reusable in a clinical setting?

    The Stone Clear (SC-LP9-01) is explicitly supplied as a reusable device, meaning it is intended for use in multiple procedures within a clinical environment like urology or gastroenterology departments.

  • What regulatory pathway was followed for FDA clearance of the Stone Clear (SC-LP9-01)?

    The Stone Clear (SC-LP9-01) received FDA 510(k) clearance through a direct submission pathway, reviewed by the Gastroenterology and Urology (GU) advisory committee. The clearance number assigned is DEN230082, and it falls under FDA regulation number 876.4690.

  • Are there any specific patient restrictions for using the Stone Clear (SC-LP9-01)?

    Yes, the Stone Clear (SC-LP9-01) is restricted for use in adult patients only, specifically for repositioning residual stone fragments that are 5 mm or smaller in the upper urinary tract after lithotripsy.

  • What clinical specialties are primarily responsible for using the Stone Clear (SC-LP9-01)?

    The Stone Clear (SC-LP9-01) is intended for use in clinical settings specializing in gastroenterology and urology, where it can assist in managing residual urinary stone fragments post-lithotripsy.