510(k) clearances

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).

Convatec · Gastroenterology, Urology

K260737Substantially EquivalentTraditionalEZD
Open FDA's page for this record
Third party flag
N
City
Flintshire
Advisory committee description
Gastroenterology, Urology
Address 1
First Ave., Deeside Industrial Estate
Address 2
Deeside
Statement or summary
Summary
Product code
EZD
Zip code
CH5 2NU
Applicant
Convatec
Decision date
2026-08-05
Decision code
SESE
Country code
GB
Advisory committee
GU
Contact
Kim Jones
K number
K260737
Date received
2026-03-06
Review advisory committee
GU
Postal code
CH5 2NU
Decision description
Substantially Equivalent
Clearance type
Traditional
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).

Harmonized identifiers (openFDA)
Device name
Catheter, Straight
Medical specialty description
Gastroenterology, Urology
Regulation number
876.5130
Device class
2
Registration number
1417592, 9612030, 3015142802, 3009632672, 3005669815, 3008132411, 3006405073, 1647149, 3005515211, 3018116884, 3005778470, 3014498861, 3006536657, 3006606901, 1000317571, 3005690789, 3033919393, 3005012805, 3023174629, 2032098, 3016675012, 1713468, 1018233, 3005941719, 3014404707, 3005562917, 9613662, 2024024, 3003974574, 3007007790, 3031571464, 3009337401, 3030671614, 9610694, 3006260740, 1061124, 1480288, 3015131144, 3011270181, 3014579161 +49 more
FEI number
1417592, 3003172243, 3015142802, 3009632672, 3000215205, 3005669815, 3008132411, 3006405073, 3003807466, 3005515211, 3018116884, 3005778470, 3014498861, 3006536657, 3006606901, 1000317571, 3005690789, 1000518731, 3002806934, 3002806731, 3033919393, 3005012805, 1000112877, 3023174629, 1000160458, 1000512168, 3016675012, 1713468, 1018233, 3014404707, 3005562917, 2024024, 3003974574, 3007007790, 3031571464, 3009337401, 3030671614, 3006260740, 1480288, 3015131144 +49 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.