Cleared Special

EASY GO VAC

K140179 · Precision Medical, Inc. · General & Plastic Surgery
Apr 2014
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

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.

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

Device Classification

Product Code BTA — Pump, Portable, Aspiration (manual Or Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4780

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