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Disposable Injection Needle AF Series

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

510(k) K230925

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

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) K230925↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK230925 Date27 Sep 2023ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K230925 decided 27 Sep 2023 Active
  • EUDAMED Active

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  • Withdrawn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
FBK
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
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.

This device is an Endoscopic Injection Needle, designed for use with an endoscope to facilitate injections during endoscopic procedures. It is intended for applications such as treating esophageal and gastric varices, as well as submucosal dye marking in gastrointestinal (GI) interventions.

The Disposable Injection Needle AF Series is supplied as a single-use, sterile device and is classified under FDA regulation 876.1500. It is intended for use in gastroenterology and urology settings, adhering to FDA 510(k) clearance (K230925) and MDR compliance. The product is available in various gauge sizes as referenced by the registration numbers, ensuring compatibility with endoscopic systems.

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