Disposable Cytology Brush (AF series)— 510(k) K241679

Substantially Equivalent

Alton (Shanghai) Medical Instruments Co., Ltd.

FDA 510(k) clearance K241679 for Disposable Cytology Brush (AF series), Substantially Equivalent on 2025-03-04. Applicant: Alton (Shanghai) Medical Instruments Co., Ltd..

Clearance details

Applicant: Alton (Shanghai) Medical Instruments Co., Ltd.
Product code: Code KTI
Advisory panel: Ear, Nose, Throat
Date received: 2024-06-11
Decision date: 2025-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code KTI

product code KTI

Malfunction: 642
Total: 642

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.