Clearance Summary
GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) received FDA 510(k) clearance under submission number K232665, sponsored by Convatec. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2024-01-25.
- Submission: K232665
- Applicant / Sponsor: Convatec
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2024-01-25
Classification & Regulation
This clearance is catalogued under FDA product code EZD and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.