K042457 is an FDA 510(k) clearance for the URO PRO. This device is classified as a System, Irrigation, Urological (Class II - Special Controls, product code LJH).
Submitted by W.O.M. World of Medicine AG (Hingham, US). The FDA issued a Cleared decision on October 25, 2004, 45 days after receiving the submission on September 10, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K042457 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2004 |
| Decision Date | October 25, 2004 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LJH — System, Irrigation, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |