K241679
- 510(k) number
- K241679
- Device name
- Disposable Cytology Brush (AF series)
- Applicant
- Alton (Shanghai) Medical Instruments Co., Ltd. CN
- Product code
- KTI — Bronchoscope Accessory
- Decision date
- 2025-03-04
- Date received
- 2024-06-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K241679.pdf
Official FDA record: K241679
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.