K230752
- 510(k) number
- K230752
- Device name
- Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)
- Applicant
- FUJIFILM Healthcare Americas Corporation MA · US
- Product code
- FED — Endoscopic Access Overtube, Gastroenterology-Urology
- Decision date
- 2023-09-15
- Date received
- 2023-03-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain
Also available from FDA: K230752.pdf
Official FDA record: K230752
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.