Cleared Traditional

K190829 - Gastrointestinal Injection Needles (VIN

K190829 is the FDA 510(k) clearance for Gastrointestinal Injection Needles (VIN by Wilson-Cook Medical Inc./Cook Endoscopy. It is a Class 2 Gastroenterology & Urology device (product code FBK) cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K190829 · Wilson-Cook Medical Inc./Cook Endoscopy · Gastroenterology & Urology device
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Dec 2019
Decision
262d
Days
Class 2
Risk

K190829 is an FDA 510(k) clearance for the Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI). Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Wilson-Cook Medical Inc./Cook Endoscopy (Winston-Salem, US). The FDA issued a Cleared decision on December 19, 2019 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 Wilson-Cook Medical Inc./Cook Endoscopy devices

Submission Details

510(k) Number K190829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2019
Decision Date December 19, 2019
Days to Decision 262 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
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 48
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K190829.
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
Clear-Jet Injection Catheter
K181690 · Finemedix Co., Ltd. · Dec 2018
Repris Bladder Injection System
K180214 · Uro-1, Inc. · May 2018
Williams Cystoscopic Injection Needle
K171602 · Cook Incorporated · Jul 2017