K945140 is an FDA 510(k) clearance for the URO-FLO. This device is classified as a System, Irrigation, Urological (Class II - Special Controls, product code LJH).
Submitted by Mallinckrodt Group, Inc. (Cincinnati, US). The FDA issued a Cleared decision on March 8, 1995, 139 days after receiving the submission on October 20, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K945140 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1994 |
| Decision Date | March 08, 1995 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | LJH — System, Irrigation, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |