Cleared Special

URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0

K982626 · Medworks Corp. · Gastroenterology & Urology

Aug 1998

Decision

23d

Days

Class 2

Risk

About This 510(k) Submission

K982626 is an FDA 510(k) clearance for the URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0, a Catheter, Retention Type, Balloon (Class II — Special Controls, product code EZL), submitted by Medworks Corp. (Pawtucket, US). The FDA issued a Cleared decision on August 20, 1998, 23 days after receiving the submission on July 28, 1998. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number	K982626 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 28, 1998
Decision Date	August 20, 1998
Days to Decision	23 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF