K232665
- 510(k) number
- K232665
- Device name
- GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)
- Applicant
- Convatec GB
- Product code
- EZD — Catheter, Straight
- Decision date
- 2024-01-25
- Date received
- 2023-08-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232665.pdf
Official FDA record: K232665
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.