K232118
- 510(k) number
- K232118
- Device name
- ANDORATE® Valve Kit
- Applicant
- Ga Health Company Limited CN
- Product code
- ODC — Endoscope Channel Accessory
- Decision date
- 2023-10-16
- Date received
- 2023-07-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K232118.pdf
Official FDA record: K232118
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.