510(k) K012362

MODIFICATION TO VASCULAR CLOSURE DEVICE by Std Mfg., Inc. — Product Code GDW

K012362 is an FDA 510(k) premarket notification submitted by Std Mfg., Inc. for the device "MODIFICATION TO VASCULAR CLOSURE DEVICE". The FDA issued a decision of Substantially Equivalent on August 23, 2001. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Std Mfg., Inc. has at least 5 other 510(k) clearances on record.