510(k) K843399

SURGEONS CHOICE PI VASCULAR STAPLING by Surgeons Choice, Inc. — Product Code GDW

K843399 is an FDA 510(k) premarket notification submitted by Surgeons Choice, Inc. for the device "SURGEONS CHOICE PI VASCULAR STAPLING". The FDA issued a decision of Substantially Equivalent on November 5, 1984. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Surgeons Choice, Inc. has at least 5 other 510(k) clearances on record.