510(k) K093897

SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR by Smith & Nephew Inc., Endoscopy Div. — Product Code MBI

K093897 is an FDA 510(k) premarket notification submitted by Smith & Nephew Inc., Endoscopy Div. for the device "SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR". The FDA issued a decision of Substantially Equivalent on March 4, 2010. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Smith & Nephew Inc., Endoscopy Div. has at least 9 other 510(k) clearances on record.