510(k) K233500

Benesta Tissue Removal Device by Caldera Medical, Inc. — Product Code HIH

K233500 is an FDA 510(k) premarket notification submitted by Caldera Medical, Inc. for the device "Benesta Tissue Removal Device". The FDA issued a decision of Substantially Equivalent on November 30, 2023. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Caldera Medical, Inc. has at least 10 other 510(k) clearances on record.