510(k) K221042

Renova RP Centesis Pump by Gi Supply, Inc. — Product Code BTA

K221042 is an FDA 510(k) premarket notification submitted by Gi Supply, Inc. for the device "Renova RP Centesis Pump". The FDA issued a decision of Substantially Equivalent on April 19, 2023. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Gi Supply, Inc. has at least 9 other 510(k) clearances on record.