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FDA 510(k)

Disposable Cytology Brush (AF series)

K-Number: K241679 · 2025-03-04

ApplicantAlton (Shanghai) Medical Instruments Co., Ltd.
Decision Date2025-03-04
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Disposable Cytology Brush (AF series) is a medical device manufactured by Alton (Shanghai) Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2025-03-04 under approval number K241679. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Cytology Brush (AF series)?

Disposable Cytology Brush (AF series) is a medical device that received FDA 510(k) clearance on 2025-03-04. It is manufactured by Alton (Shanghai) Medical Instruments Co., Ltd.. The 510(k) number is K241679.

When was Disposable Cytology Brush (AF series) approved by the FDA?

Disposable Cytology Brush (AF series) received FDA 510(k) clearance on 2025-03-04, under approval number K241679.

What company makes Disposable Cytology Brush (AF series)?

Disposable Cytology Brush (AF series) is manufactured by Alton (Shanghai) Medical Instruments Co., Ltd..

What is the FDA product code for Disposable Cytology Brush (AF series)?

The FDA product code for Disposable Cytology Brush (AF series) is KTI.

Other Devices by Alton (Shanghai) Medical Instruments Co., Ltd.

K230925Disposable Injection Needle AF series K241285Disposable Endoscope Valves Set (AF series) K231633Disposable Hemoclip (AF series) K243039Ureteral Stents (AF-D series) K242635Endoscopic Distal Attachment (AF-D series)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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