K040094 is an FDA 510(k) clearance for the PIGGYBACK IRRIGATING SYSTEM, a System, Irrigation, Urological (Class II — Special Controls, product code LJH), submitted by Kosin Technologies, LLC (Valparaiso, US). The FDA issued a Cleared decision on April 15, 2004, 90 days after receiving the submission on January 16, 2004. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K040094 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 16, 2004 |
| Decision Date | April 15, 2004 |
| Days to Decision | 90 days |
| Submission Type | Abbreviated |
| 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 |