510(k) K061548

STRYKER URETERAL ILLUMINATION SYSTEM IV by Stryker Corp. — Product Code FCS

K061548 is an FDA 510(k) premarket notification submitted by Stryker Corp. for the device "STRYKER URETERAL ILLUMINATION SYSTEM IV". The FDA issued a decision of Substantially Equivalent on September 28, 2006. The device falls under product code FCS (Light, Catheter, Fiberoptic, Glass, Ureteral), a Class II device regulated under 21 CFR 876.4020. Stryker Corp. has at least 10 other 510(k) clearances on record.