510(k) K041806

PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOP by Depuy Mitek, A Johnson & Johnson Company — Product Code GAM

K041806 is an FDA 510(k) premarket notification submitted by Depuy Mitek, A Johnson & Johnson Company for the device "PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOP". The FDA issued a decision of Substantially Equivalent on Aug 3, 2004. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Depuy Mitek, A Johnson & Johnson Company has 61 other 510(k) clearances on record.