K232028
- 510(k) number
- K232028
- Device name
- Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)
- Applicant
- Iq Endoscopes Limited GB
- Product code
- FDS — Gastroscope And Accessories, Flexible/Rigid
- Decision date
- 2023-11-17
- Date received
- 2023-07-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K232028.pdf
Official FDA record: K232028
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.