Cleared Traditional

SnapLoc Wire Lock (K213483) - FDA 510(k) Clearance

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

K213483 · Wilson Cook Medical · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Apr 2022
Decision
179d
Days
Class 2
Risk

K213483 is an FDA 510(k) clearance for the SnapLoc Wire Lock. Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by Wilson Cook Medical (Winston-Salem, US). The FDA issued a Cleared decision on April 26, 2022 after a review of 179 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 devices

Submission Details

510(k) Number K213483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2021
Decision Date April 26, 2022
Days to Decision 179 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
49d slower than avg
Panel avg: 130d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODC Endoscope Channel Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Give The Endoscope Channel Additional Or Improved Functionality.
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 - ODC Endoscope Channel Accessory

All 46
Devices cleared under the same product code (ODC) and FDA review panel - the closest regulatory comparables to K213483.
Disposable Endoscope Valves System
K221331 · Changzhou Endoclean Medical Device Co., Ltd. · Sep 2022
Disposable Endoscopy Adapter Set
K220210 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Jun 2022
FROG Forceps Valve (VAL1-F1-100)
K221264 · Fujifilm Medwork GmbH · Jun 2022
Guidewire Locking Device
K220247 · Micro-Tech (Nanjing) Co., Ltd. · Mar 2022
Wellead Endoscopic Seal
K211814 · Well Lead Medical Co., Ltd. · Jan 2022
andorate Suction Valve, andorate Air/Water Valve
K213095 · Ga Health Company Limited · Jan 2022