Ultrasonic Urinary Stone Propulsion Device

QNA · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.4690

Classification

FDA Product Code: QNA
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.4690
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown