Cleared Traditional

K232200 - Disposable Injection Needles (FDA 510(k) Clearance)

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

K232200 · Ningbo Xinwell Medical Technology Co., Ltd. · Gastroenterology & Urology device
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Apr 2024
Decision
262d
Days
Class 2
Risk

K232200 is an FDA 510(k) clearance for the Disposable Injection Needles. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Ningbo Xinwell Medical Technology Co., Ltd. (Ningbo Cixi, CN). The FDA issued a Cleared decision on April 12, 2024 after a review of 262 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 Ningbo Xinwell Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K232200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2023
Decision Date April 12, 2024
Days to Decision 262 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 130d · This submission: 262d
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 86
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K232200.
Disposable Endoscopic Injection Needles
K252021 · Changzhou New Med Micro-Medtech Co., Ltd. · Dec 2025
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K241595 · Veol Medical Technologies Pvt , Ltd. · Feb 2025
Endoscopic Injection Needles
K240675 · Promisemed Hangzhou Meditech Co., Ltd. · Oct 2024
injeTAK Adjustable Tip Needle (DIS199
K241523 · Laborie Medical Technologies, Corp. · Aug 2024
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