K232997
- 510(k) number
- K232997
- Device name
- EVIS Exera III Gastrointestinal Videoscope GIF-1TH190
- Applicant
- Olympus Medical Systems Corporation JP
- Product code
- FDS — Gastroscope And Accessories, Flexible/Rigid
- Decision date
- 2024-06-19
- Date received
- 2023-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K232997.pdf
Official FDA record: K232997
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.