510(k) K982626

URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0 by Medworks Corp. — Product Code EZL

K982626 is an FDA 510(k) premarket notification submitted by Medworks Corp. for the device "URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0". The FDA issued a decision of Substantially Equivalent on August 20, 1998. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Medworks Corp. has at least 2 other 510(k) clearances on record.