Cleared Traditional

K141820 - JAGWIRE HIGH PERFORMANCE GUIDWIRE

K141820 is an FDA 510(k) clearance for JAGWIRE HIGH PERFORMANCE GUIDWIRE, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code OCY cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K141820 · Boston Scientific Corp · Gastroenterology & Urology device
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Oct 2014
Decision
106d
Days
Class 2
Risk

K141820 is an FDA 510(k) clearance for the JAGWIRE HIGH PERFORMANCE GUIDWIRE. Classified as Endoscopic Guidewire, Gastroenterology-urology (product code OCY), Class II - Special Controls.

Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on October 21, 2014 after a review of 106 days - within the typical 510(k) review window.

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 Boston Scientific Corp devices

FDA 510(k) Submission Details - K141820

510(k) Number K141820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2014
Decision Date October 21, 2014
Days to Decision 106 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
25d faster than avg
Panel avg: 131d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCY Device Classification - Class 2, Special Controls

Product Code OCY Endoscopic Guidewire, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Provide Access To Gi Or Gu Tract For The Purpose Of Passing Or Exchanging Other Accessories.
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 - OCY Endoscopic Guidewire, Gastroenterology-urology

All 37
Devices cleared under the same product code (OCY) and FDA review panel - the closest regulatory comparables to K141820.
Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff
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K142397 · Lake Region Medical · Sep 2014
MANDREL GUIDEWIRE
K140482 · Lake Region Medical · Apr 2014
NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
K133076 · Neometrics, Inc. · Feb 2014