Disposable Endoscope Injection Needles— 510(k) K232442

Name: FDA 510(k) clearance K232442
Creator: U.S. Food and Drug Administration
Published: 2023-11-09

Substantially Equivalent

Zhejiang Soudon Medical Technology Co., Ltd.

FDA 510(k) clearance K232442 for Disposable Endoscope Injection Needles, Substantially Equivalent on 2023-11-09. Applicant: Zhejiang Soudon Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Zhejiang Soudon Medical Technology Co., Ltd.
Product code: Code FBK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2023-08-14
Decision date: 2023-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FBK

view all

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 Zhejiang Soudon Medical Technology Co., Ltd.

view all

K253013 — Disposable Stone Retrieval Balloon Catheter2026-05-08
K253056 — Disposable Stone Extraction Basket2026-04-03
K232450 — Disposable Hemostatic Clips2024-01-26
K232476 — Disposable Sphincterotome2023-11-07

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.