Submission Details
| 510(k) Number | K140179 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 24, 2014 |
| Decision Date | April 25, 2014 |
| Days to Decision | 91 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
K140179 is an FDA 510(k) clearance for the EASY GO VAC, a Pump, Portable, Aspiration (manual Or Powered) (Class II — Special Controls, product code BTA), submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on April 25, 2014, 91 days after receiving the submission on January 24, 2014. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K140179 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 24, 2014 |
| Decision Date | April 25, 2014 |
| Days to Decision | 91 days |
| Submission Type | Special |
| 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 |