510(k) K253677

Tembo Embolic System by Instylla, Inc. — Product Code KRD

K253677 is an FDA 510(k) premarket notification submitted by Instylla, Inc. for the device "Tembo Embolic System". The FDA issued a decision of Substantially Equivalent on December 15, 2025. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Instylla, Inc. has at least 9 other 510(k) clearances on record.