K040461 is an FDA 510(k) clearance for the ECONOLITH E3000, MODEL 3000 (SW-6). This device is classified as a Lithotriptor, Extracorporeal Shock-wave, Urological (Class II - Special Controls, product code LNS).
Submitted by Medispec, Ltd. (Germantown, US). The FDA issued a Cleared decision on May 25, 2004, 92 days after receiving the submission on February 23, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5990.
| 510(k) Number | K040461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2004 |
| Decision Date | May 25, 2004 |
| Days to Decision | 92 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 |