Cleared Traditional

Sclerotherapy & Endoscopic Needles (K222006) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222006 · G-Flex Europe Sprl · Gastroenterology & Urology device
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Apr 2023
Decision
270d
Days
Class 2
Risk

K222006 is an FDA 510(k) clearance for the Sclerotherapy & Endoscopic Needles. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by G-Flex Europe Sprl (Nivelles, BE). The FDA issued a Cleared decision on April 3, 2023 after a review of 270 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all G-Flex Europe Sprl devices

Submission Details

510(k) Number K222006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2022
Decision Date April 03, 2023
Days to Decision 270 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 130d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FBK Endoscopic Injection Needle, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FBK Endoscopic Injection Needle, Gastroenterology-urology

All 35
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K222006.
Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)
K232826 · Steris · Mar 2024
Disposable Endoscope Injection Needles
K232442 · Zhejiang Soudon Medical Technology Co., Ltd. · Nov 2023
Disposable Injection Needle AF series
K230925 · Alton (Shanghai) Medical Instruments Co., Ltd. · Sep 2023
CORE-INJECTOR
K221054 · Incore Co., Ltd. · Dec 2022
LiNA OperaScope Needle
K221085 · Lina Medical Aps · Sep 2022
Disposable Endoscope Injection Needle
K220292 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Aug 2022