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Disposable Cytology Brush AF Series

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

510(k) K241679

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241679↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK241679 Date4 Mar 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
KTI
Device Class
Class II
Regulation
21 CFR Part 874.4680
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Disposable Cytology Brush AF Series is a single-use medical device classified as a Bronchoscope Accessory, designed for the collection of cytological samples from the respiratory tract. It features a sterile, disposable brush tip intended for gentle yet effective sampling during endoscopic procedures, particularly in Ear, Nose, and Throat (ENT) applications.

Supplied as a sterile, disposable device, the AF Series brush is intended for single-use only and must be discarded after use to prevent cross-contamination. It is regulated under 21 CFR 874.4680 and has received FDA 510(k) clearance (K241679) and MDR authorization, ensuring compliance with medical device standards. The device is not MRI-safe and must be stored in a clean, dry environment as per manufacturer guidelines.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary use of the Disposable Cytology Brush (AF series) in clinical practice?

    The Disposable Cytology Brush (AF series) is designed specifically for collecting cytological samples from the respiratory tract during endoscopic procedures, particularly in Ear, Nose, and Throat (ENT) applications. Its gentle yet effective brush tip is intended for sampling tissues in these areas, ensuring accurate diagnostic material collection.

  • Is the Disposable Cytology Brush (AF series) reusable or intended for single-use only?

    The device is explicitly labeled for single-use only to prevent cross-contamination. After use, it must be discarded to maintain sterility and comply with manufacturer guidelines.

  • How should the Disposable Cytology Brush (AF series) be stored before use?

    The device must be stored in a clean, dry environment as per manufacturer instructions. It is supplied sterile, so storage conditions should preserve its integrity until use.

  • What regulatory pathways has the Disposable Cytology Brush (AF series) undergone?

    The device has received FDA 510(k) clearance (K241679) under 21 CFR 874.4680 and MDR authorization, ensuring compliance with medical device regulations in the U.S. and EU markets.