SOMAVAC Device

FDA 510(k) K180606 · Somavac Medical Solutions, Inc.

Substantially Equivalent

510(k) numberK180606

Submission

Device name
SOMAVAC Device
Applicant
Somavac Medical Solutions, Inc.
Memphis, TN, US
Received
March 7, 2018
Decision date
May 31, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 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 SOMAVAC Device cleared by the FDA?

SOMAVAC Device (K180606) received a 510(k) decision of Substantially Equivalent on May 31, 2018, 85 days after the submission was received.

What is the product code of K180606?

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