Disposable Endoscope Injection Needle— 510(k) K220292

Name: FDA 510(k) clearance K220292
Creator: U.S. Food and Drug Administration
Published: 2022-08-19

Substantially Equivalent

Yangzhou Fartley Medical Instrument Technology Co., Ltd.

FDA 510(k) clearance K220292 for Disposable Endoscope Injection Needle, Substantially Equivalent on 2022-08-19. Applicant: Yangzhou Fartley Medical Instrument Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Product code: Code FBK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2022-02-01
Decision date: 2022-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FBK

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K260262 — Injection Needle2026-05-29
K253598 — InjecSURE Injection System2026-03-31
K252021 — Disposable Endoscopic Injection Needles2025-12-02
K252247 — Injector Force Max Single Use Injector (4 models)2025-10-16
K241595 — EzVu Visual Vasopressor injector (EV-19)2025-02-27

More clearances from Yangzhou Fartley Medical Instrument Technology Co., Ltd.

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K260423 — Disposable Endoscopic Distal Attachments2026-05-28
K250732 — Disposable Endoscopy Valve Set2025-06-20
K230004 — Disposable Hemoclip2023-07-31
K222980 — Pentax Medical Valve Set2022-11-21
K220785 — Clean Connecting Tube2022-09-27

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.