K161002 is an FDA 510(k) clearance for the Aprima Smartesis Centesis Pump. This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on September 28, 2016, 170 days after receiving the submission on April 11, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K161002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2016 |
| Decision Date | September 28, 2016 |
| Days to Decision | 170 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 |