Cleared Traditional

K212668 - Sclerotherapy Needle

K212668 is an FDA 510(k) clearance for Sclerotherapy Needle, manufactured by Zhejiang Chuangxiang Medical Technology Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FBK cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K212668 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Gastroenterology & Urology device
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Feb 2022
Decision
184d
Days
Class 2
Risk

K212668 is an FDA 510(k) clearance for the Sclerotherapy Needle. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Zhejiang Chuangxiang Medical Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on February 23, 2022 after a review of 184 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 Zhejiang Chuangxiang Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K212668

510(k) Number K212668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2021
Decision Date February 23, 2022
Days to Decision 184 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
54d slower than avg
Panel avg: 130d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FBK Device Classification - Class 2, Special Controls

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 52
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K212668.
Disposable Endoscope Injection Needle
K220292 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Aug 2022
Injection Needle
K213914 · Jiangsu Vedkang Medical Science and Technology Co., Ltd. · Jul 2022
Endoscopic Injection Needle
K213239 · Beijing Zksk Technology Co., Ltd. · Jun 2022
Single Use Injection Needle
K210917 · Anrei Medical (Hangzhou) Co., Ltd. · May 2021
Single Use Injector
K192498 · Olympus Medical Systems Corp. · Apr 2020
Disposable Sclerotherapy Needle
K190032 · Hangzhou AGS MedTech Co., Ltd. · Feb 2020