K173389 is an FDA 510(k) clearance for the Rex Medical Aspiration Pump. This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).
Submitted by Rex Medical, L.P. (Conshohocken, US). The FDA issued a Cleared decision on January 30, 2018, 92 days after receiving the submission on October 30, 2017.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K173389 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2017 |
| Decision Date | January 30, 2018 |
| Days to Decision | 92 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 |