Easy Go Vac

FDA 510(k) K140179 · Precision Medical, Inc.

Substantially Equivalent

510(k) numberK140179

Submission

Device name
Easy Go Vac
Applicant
Precision Medical, Inc.
Northampton, PA, US
Received
January 24, 2014
Decision date
April 25, 2014
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BTA – Pump, Portable, Aspiration (Manual Or Powered)
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4780
Specialty
General, Plastic Surgery

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Questions and answers

When was Easy Go Vac cleared by the FDA?

Easy Go Vac (K140179) received a 510(k) decision of Substantially Equivalent on April 25, 2014, 91 days after the submission was received.

What is the product code of K140179?

The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.