510(k) K093112

DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE by Coloplast Manufacturing Us, LLC — Product Code GAW

K093112 is an FDA 510(k) premarket notification submitted by Coloplast Manufacturing Us, LLC for the device "DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE". The FDA issued a decision of Substantially Equivalent on February 1, 2010. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Coloplast Manufacturing Us, LLC has at least 3 other 510(k) clearances on record.