About This 510(k) Submission
K250699 is an FDA 510(k) clearance for the Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K), a Catheter, Straight (Class II — Special Controls, product code EZD), submitted by Convatec (Flintshire, GB). The FDA issued a Cleared decision on July 1, 2025, 116 days after receiving the submission on March 7, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.