K013417 is an FDA 510(k) clearance for the MISONIX IRRIGATION SYSTEM MOEDL BC20P. This device is classified as a Catheter, Irrigation (Class I - General Controls, product code GBX).
Submitted by Misonix, Inc. (Farmingdale, US). The FDA issued a Cleared decision on January 10, 2002, 87 days after receiving the submission on October 15, 2001.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K013417 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2001 |
| Decision Date | January 10, 2002 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GBX - Catheter, Irrigation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |