510(k) K022410

SAPH-LOOP LIGATING LOOP by Genzyme Biosurgery — Product Code GAT

K022410 is an FDA 510(k) premarket notification submitted by Genzyme Biosurgery for the device "SAPH-LOOP LIGATING LOOP". The FDA issued a decision of Substantially Equivalent on August 20, 2002. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Genzyme Biosurgery has at least 3 other 510(k) clearances on record.