510(k) K161294

Compound W Wart Removal System Dual Power by Medtech Products, Inc. — Product Code GEH

K161294 is an FDA 510(k) premarket notification submitted by Medtech Products, Inc. for the device "Compound W Wart Removal System Dual Power". The FDA issued a decision of Substantially Equivalent on September 15, 2016. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Medtech Products, Inc. has at least 10 other 510(k) clearances on record.