510(k) K100251

G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 by Usgi Medical — Product Code GAT

K100251 is an FDA 510(k) premarket notification submitted by Usgi Medical for the device "G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333". The FDA issued a decision of Substantially Equivalent on February 17, 2010. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Usgi Medical has at least 10 other 510(k) clearances on record.