510(k) K183578

Torpedo Gelatin Foam by Biosphere Medical, S.A. — Product Code KRD

K183578 is an FDA 510(k) premarket notification submitted by Biosphere Medical, S.A. for the device "Torpedo Gelatin Foam". The FDA issued a decision of Substantially Equivalent on June 18, 2019. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Biosphere Medical, S.A. has at least 10 other 510(k) clearances on record.