Cleared Traditional

K250699 - Cure Twist Female 8 Catheter (T8) (FDA 510(k) Clearance)

Also includes:

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)

K250699 · Convatec · Gastroenterology & Urology device

Jul 2025

Decision

116d

Days

Class 2

Risk

K250699 is an FDA 510(k) clearance for the Cure Twist Female 8 Catheter (T8). This device is classified as 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 FDA review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number	K250699 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 07, 2025
Decision Date	July 01, 2025
Days to Decision	116 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF