K121656 is an FDA 510(k) clearance for the GEMINI 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 24, 2012, 111 days after receiving the submission on June 5, 2012.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5990.
| 510(k) Number | K121656 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2012 |
| Decision Date | September 24, 2012 |
| Days to Decision | 111 days |
| Submission Type | Special |
| 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 |