K234145
- 510(k) number
- K234145
- Device name
- ViSiGi 3D Gastric Sizing Tube
- Applicant
- Boehringer Laboratories PA · US
- Product code
- KNT — Tubes, Gastrointestinal (And Accessories)
- Decision date
- 2024-01-26
- Date received
- 2023-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K234145.pdf
Official FDA record: K234145
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.