510(k) K090159

INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES by Incisive Surgical, Inc. — Product Code GDW

K090159 is an FDA 510(k) premarket notification submitted by Incisive Surgical, Inc. for the device "INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES". The FDA issued a decision of Substantially Equivalent on February 6, 2009. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Incisive Surgical, Inc. has at least 4 other 510(k) clearances on record.