510(k) K860030

SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID by Surgidyne, Inc. — Product Code BTA

K860030 is an FDA 510(k) premarket notification submitted by Surgidyne, Inc. for the device "SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID". The FDA issued a decision of Substantially Equivalent on February 12, 1986. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Surgidyne, Inc. has at least 5 other 510(k) clearances on record.