K242336
- 510(k) number
- K242336
- Device name
- hygh-tec Drainage II
- Applicant
- Amb Medtec DE
- Product code
- KNT — Tubes, Gastrointestinal (And Accessories)
- Decision date
- 2025-01-17
- Date received
- 2024-08-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K242336.pdf
Official FDA record: K242336
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.