Cleared Special

Delta III Lithotripter

K172084 · Dornier Medtech America, Inc. · Gastroenterology & Urology
Aug 2017
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K172084 is an FDA 510(k) clearance for the Delta III Lithotripter, a Lithotriptor, Extracorporeal Shock-wave, Urological (Class II — Special Controls, product code LNS), submitted by Dornier Medtech America, Inc. (Kennesaw, US). The FDA issued a Cleared decision on August 8, 2017, 29 days after receiving the submission on July 10, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5990.

Submission Details

510(k) Number K172084 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 2017
Decision Date August 08, 2017
Days to Decision 29 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code LNS — Lithotriptor, Extracorporeal Shock-wave, Urological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5990

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