Cleared Traditional

Disposable Sclerotherapy Needle (K190032) - FDA 510(k) Clearance

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

K190032 · Hangzhou AGS MedTech Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
416d
Days
Class 2
Risk

K190032 is an FDA 510(k) clearance for the Disposable Sclerotherapy Needle. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Hangzhou AGS MedTech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on February 27, 2020 after a review of 416 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Hangzhou AGS MedTech Co., Ltd. devices

Submission Details

510(k) Number K190032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2019
Decision Date February 27, 2020
Days to Decision 416 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
286d slower than avg
Panel avg: 130d · This submission: 416d
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 K190032.
Sclerotherapy Needle
K212668 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Feb 2022
Single Use Injection Needle
K210917 · Anrei Medical (Hangzhou) Co., Ltd. · May 2021
Single Use Injector
K192498 · Olympus Medical Systems Corp. · Apr 2020
Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)
K190829 · Wilson-Cook Medical Inc./Cook Endoscopy · Dec 2019
Clear-Jet Injection Catheter
K181690 · Finemedix Co., Ltd. · Dec 2018
Repris Bladder Injection System
K180214 · Uro-1, Inc. · May 2018