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)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250699 · Convatec · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
116d
Days
Class 2
Risk

K250699 is an FDA 510(k) clearance for the Cure Twist Female 8 Catheter (T8). Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Convatec (Flintshire, GB). The FDA issued a Cleared decision on July 1, 2025 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Convatec devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 130d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZD Catheter, Straight
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - EZD Catheter, Straight

All 80
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