K201074 is an FDA 510(k) clearance for the Delta III Lithotripter. This device is classified as 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 September 3, 2020, 134 days after receiving the submission on April 22, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5990.
| 510(k) Number | K201074 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2020 |
| Decision Date | September 03, 2020 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LNS — Lithotriptor, Extracorporeal Shock-wave, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5990 |