K241285
- 510(k) number
- K241285
- Device name
- Disposable Endoscope Valves Set (AF series)
- Applicant
- Alton (Shanghai) Medical Instruments Co., Ltd. CN
- Product code
- ODC — Endoscope Channel Accessory
- Decision date
- 2024-10-01
- Date received
- 2024-05-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K241285.pdf
Official FDA record: K241285
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.