510(k) K000608

SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM by Std Mfg., Inc. — Product Code GDW

K000608 is an FDA 510(k) premarket notification submitted by Std Mfg., Inc. for the device "SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 7, 2000. 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.