meddevicedb.com FDA Device Reference

Stone Clear (SC-LP9-01)

DEN230082 Class II Direct
Decision Date
2024-10-30
Sponsor / Applicant
Sonomotion, Inc.

Technical Specification

510(k) Submission ID DEN230082
Product Code QNA
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.4690
Decision Date 2024-10-30
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Stone Clear (SC-LP9-01) received FDA 510(k) clearance under submission number DEN230082, sponsored by Sonomotion, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2024-10-30.

Classification & Regulation

This clearance is catalogued under FDA product code QNA and 21 CFR 876.4690, within the Gastroenterology, Urology review panel as a Class II device.