Disposable Injection Needle AF series— 510(k) K230925

Name: FDA 510(k) clearance K230925
Creator: U.S. Food and Drug Administration
Published: 2023-09-27

Substantially Equivalent

Alton (Shanghai) Medical Instruments Co., Ltd.

FDA 510(k) clearance K230925 for Disposable Injection Needle AF series, Substantially Equivalent on 2023-09-27. Applicant: Alton (Shanghai) Medical Instruments Co., Ltd.. Device class: 2.

Clearance details

Applicant: Alton (Shanghai) Medical Instruments Co., Ltd.
Product code: Code FBK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2023-04-03
Decision date: 2023-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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K252247 — Injector Force Max Single Use Injector (4 models)2025-10-16
K241595 — EzVu Visual Vasopressor injector (EV-19)2025-02-27

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K243039 — Ureteral Stents (AF-D series)2025-06-18
K242635 — Endoscopic Distal Attachment (AF-D series)2025-05-30
K241679 — Disposable Cytology Brush (AF series)2025-03-04
K241285 — Disposable Endoscope Valves Set (AF series)2024-10-01
K231633 — Disposable Hemoclip (AF series)2024-01-11

Adverse events under product code FBK

product code FBK

Other: 1
Total: 1

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.