510(k) K070846

MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM by Prosurg, Inc. — Product Code FTL

K070846 is an FDA 510(k) premarket notification submitted by Prosurg, Inc. for the device "MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 2, 2007. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Prosurg, Inc. has at least 10 other 510(k) clearances on record.