K243820
- 510(k) number
- K243820
- Device name
- Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250
- Applicant
- Dornier Medtech America GA · US
- Product code
- FED — Endoscopic Access Overtube, Gastroenterology-Urology
- Decision date
- 2025-01-31
- Date received
- 2024-12-12
- 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: K243820.pdf
Official FDA record: K243820
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.