510(k) K260737
K260737 is an FDA 510(k) premarket notification submitted by Convatec for the device "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).". The FDA issued a decision of Substantially Equivalent on Aug 5, 2026. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Convatec has 18 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 5, 2026
- Date Received
- Mar 6, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Catheter, Straight
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type
- 510(k)