510(k) K021397

EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION by Biosphere Medical, Inc. — Product Code NAJ

K021397 is an FDA 510(k) premarket notification submitted by Biosphere Medical, Inc. for the device "EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION". The FDA issued a decision of Substantially Equivalent on November 22, 2002. The device falls under product code NAJ (Agents, Embolic, For Treatment Of Uterine Fibroids), a Class II device regulated under 21 CFR 870.3300. Biosphere Medical, Inc. has at least 10 other 510(k) clearances on record.