Sclerotherapy & Endoscopic Needles— 510(k) K222006

Name: FDA 510(k) clearance K222006
Creator: U.S. Food and Drug Administration
Published: 2023-04-03

Substantially Equivalent

G-Flex Europe Sprl

FDA 510(k) clearance K222006 for Sclerotherapy & Endoscopic Needles, Substantially Equivalent on 2023-04-03. Applicant: G-Flex Europe Sprl. Device class: 2.

Clearance details

Applicant: G-Flex Europe Sprl
Product code: Code FBK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2022-07-07
Decision date: 2023-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nivelles, BE

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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K211909 — Cysto-Gastro-Sets2022-06-09

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.