K033335 is an FDA 510(k) clearance for the LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS. This device is classified as a Table, Cystometric, Electric (Class II - Special Controls, product code MMZ).
Submitted by Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on November 25, 2003, 40 days after receiving the submission on October 16, 2003.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4890.
| 510(k) Number | K033335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 2003 |
| Decision Date | November 25, 2003 |
| Days to Decision | 40 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MMZ — Table, Cystometric, Electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4890 |