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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 the device name listed in this FDA 510(k) record. The listed applicant is Alton (Shanghai) Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2025-03-04 under 510(k) 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. The listed applicant is Alton (Shanghai) Medical Instruments Co., Ltd.. The 510(k) number is K241679.

When did Disposable Cytology Brush (AF series) receive FDA 510(k) clearance?

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

Who is the listed applicant for Disposable Cytology Brush (AF series)?

The FDA 510(k) record lists Alton (Shanghai) Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Alton (Shanghai) Medical Instruments Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: KTI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm ScopesCook Ireland, Ltd.K251478ClearTip TBNA TypeFinemedix Co., Ltd.K254040LungFlow Basket CatheterFree Flow Medical, Inc.K251402LIA-1 Catheter (542-1)Leadoptik, Inc.K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01Serpex Medical, Inc.K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation

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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