510(k) K970416

ACUFEX DOUBLE ARMED SUTURE NEEDLE by Smith & Nephew Endoscopy, Inc. — Product Code GAT

K970416 is an FDA 510(k) premarket notification submitted by Smith & Nephew Endoscopy, Inc. for the device "ACUFEX DOUBLE ARMED SUTURE NEEDLE". The FDA issued a decision of Substantially Equivalent on April 21, 1997. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Smith & Nephew Endoscopy, Inc. has at least 10 other 510(k) clearances on record.