510(k) K231063

SOMAVAC® 100 Sustained Vacuum System by Somavac Medical Solutions, Inc. — Product Code BTA

K231063 is an FDA 510(k) premarket notification submitted by Somavac Medical Solutions, Inc. for the device "SOMAVAC® 100 Sustained Vacuum System". The FDA issued a decision of Substantially Equivalent on May 12, 2023. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Somavac Medical Solutions, Inc. has at least 2 other 510(k) clearances on record.