K242635
- 510(k) number
- K242635
- Device name
- Endoscopic Distal Attachment (AF-D series)
- Applicant
- Alton (Shanghai) Medical Instruments Co., Ltd. CN
- Product code
- FDS — Gastroscope And Accessories, Flexible/Rigid
- Decision date
- 2025-05-30
- Date received
- 2024-09-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K242635.pdf
Official FDA record: K242635
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.