Cleared Traditional

K161026 - NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) (FDA 510(k) Clearance)

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

K161026 · Marvao Medical Devices, Ltd. · Gastroenterology & Urology device

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Aug 2016

Decision

119d

Days

Class 2

Risk

K161026 is an FDA 510(k) clearance for the NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 3.... Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Marvao Medical Devices, Ltd. (Galway, IE). The FDA issued a Cleared decision on August 9, 2016 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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.

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Submission Details

510(k) Number	K161026 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received	April 12, 2016
Decision Date	August 09, 2016
Days to Decision	119 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

11d faster than avg

Panel avg: 130d · This submission: 119d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	MSD Catheter, Hemodialysis, Implanted
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 876.5540

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.