510(k) K943801

URIGLOW TRANSILLUMINATING URETERIC STENT MODEL by Rocket of London, Ltd. — Product Code FCS

K943801 is an FDA 510(k) premarket notification submitted by Rocket of London, Ltd. for the device "URIGLOW TRANSILLUMINATING URETERIC STENT MODEL". The FDA issued a decision of Substantially Equivalent on August 15, 1995. The device falls under product code FCS (Light, Catheter, Fiberoptic, Glass, Ureteral), a Class II device regulated under 21 CFR 876.4020. Rocket of London, Ltd. has at least 2 other 510(k) clearances on record.