Cleared Special

K140482 - MANDREL GUIDEWIRE

K140482 is an FDA 510(k) clearance for MANDREL GUIDEWIRE, manufactured by Lake Region Medical. The device is a Class 2 Gastroenterology & Urology device with product code OCY cleared through the Special 510(k) pathway after a 41-day FDA review.

K140482 · Lake Region Medical · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Apr 2014
Decision
41d
Days
Class 2
Risk

K140482 is an FDA 510(k) clearance for the MANDREL GUIDEWIRE. Classified as Endoscopic Guidewire, Gastroenterology-urology (product code OCY), Class II - Special Controls.

Submitted by Lake Region Medical (Chaska, US). The FDA issued a Cleared decision on April 8, 2014 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Lake Region Medical devices

FDA 510(k) Submission Details - K140482

510(k) Number K140482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2014
Decision Date April 08, 2014
Days to Decision 41 days
Submission Type Special
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
90d faster than avg
Panel avg: 131d · This submission: 41d
Pathway characteristics
Modification to existing cleared device.

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 39
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