510(k) K042531

UPDATED SLIP UROLOGY INTRODUCER SHEATH by Percutaneous Systems, Incorporated — Product Code KNY

K042531 is an FDA 510(k) premarket notification submitted by Percutaneous Systems, Incorporated for the device "UPDATED SLIP UROLOGY INTRODUCER SHEATH". The FDA issued a decision of Substantially Equivalent on February 1, 2005. The device falls under product code KNY (Accessories, Catheter, G-U), a Class II device regulated under 21 CFR 876.5130. Percutaneous Systems, Incorporated has at least 4 other 510(k) clearances on record.