K070665 is an FDA 510(k) clearance for the LITHOSKOP. This device is classified as a Lithotriptor, Extracorporeal Shock-wave, Urological (Class II - Special Controls, product code LNS).
Submitted by Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on January 4, 2008, 298 days after receiving the submission on March 12, 2007.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5990.
| 510(k) Number | K070665 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2007 |
| Decision Date | January 04, 2008 |
| Days to Decision | 298 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 |