K252943
- 510(k) number
- K252943
- Device name
- GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women
- Applicant
- Convatec Limited GB
- Product code
- EZD — Catheter, Straight
- Decision date
- 2026-04-01
- Date received
- 2025-09-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K252943.pdf
Official FDA record: K252943
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.