510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230082Unknown

Stone Clear (SC-LP9-01)

Sonomotion, Inc., San Mateo CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN230082 is the FDA 510(k) clearance record for Stone Clear (SC-LP9-01), a class II device, cleared for Sonomotion, Inc. on under FDA product code QNA (Ultrasonic Urinary Stone Propulsion Device). FDA's definition for product code QNA reads: "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". FDA records list 4 510(k) clearances for Sonomotion, Inc., from to . As of , FDA records show no recalls naming DEN230082.

Clearance record

Decision date
Received
(328 days to decision)
Product code
QNA Ultrasonic Urinary Stone Propulsion Device
Regulation
21 CFR 876.4690
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Sonomotion, Inc. 1600 W. Hillsdale Blvd., Suite 105, San Mateo CA
Third party review
No

Clearances, product code QNA

Trailing 12 months
1 clearance under product code QNA in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QNA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260