K122619 is an FDA 510(k) clearance for the EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET. This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).
Submitted by Applied Medical (Rancho Santa, US). The FDA issued a Cleared decision on October 2, 2012, 35 days after receiving the submission on August 28, 2012.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K122619 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2012 |
| Decision Date | October 02, 2012 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | BTA - Pump, Portable, Aspiration (manual Or Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4780 |