Disposable Endoscopic Injection Needles— 510(k) K252021

Name: FDA 510(k) clearance K252021
Creator: U.S. Food and Drug Administration
Published: 2025-12-02

Substantially Equivalent

Changzhou New Med Micro-Medtech Co., Ltd.

FDA 510(k) clearance K252021 for Disposable Endoscopic Injection Needles, Substantially Equivalent on 2025-12-02. Applicant: Changzhou New Med Micro-Medtech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Changzhou New Med Micro-Medtech Co., Ltd.
Product code: Code FBK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2025-06-30
Decision date: 2025-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, 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
K252247 — Injector Force Max Single Use Injector (4 models)2025-10-16
K241595 — EzVu Visual Vasopressor injector (EV-19)2025-02-27
K240675 — Endoscopic Injection Needles2024-10-04

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.