Cleared Special

UreTron PF Series Probe

K162119 · Med-Sonics Corp. · Gastroenterology & Urology
Aug 2016
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K162119 is an FDA 510(k) clearance for the UreTron PF Series Probe, a Lithotriptor, Electro-hydraulic (Class II — Special Controls, product code FFK), submitted by Med-Sonics Corp. (Erie, US). The FDA issued a Cleared decision on August 29, 2016, 28 days after receiving the submission on August 1, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4480.

Submission Details

510(k) Number K162119 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2016
Decision Date August 29, 2016
Days to Decision 28 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code FFK — Lithotriptor, Electro-hydraulic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4480

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