Atlas FDA

Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).

FDA 510(k) clearance K260737 · decided 2026-08-05

Clearance details

K-number
K260737
Device name
Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).
Applicant
Convatec
Decision
Substantially Equivalent
Date received
2026-03-06
Decision date
2026-08-05
Days to decision
152 days
Clearance type
Traditional
Product code
EZD
Device class
2
Regulation number
876.5130
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Flintshire, GB
Third-party review
No
Expedited review
No

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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) (K250699)Convatec2025-07-01

Recalls involving this device

No recalls on record reference this clearance.