Cleared Special

K202176 - Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K202176 · Medical Components, Inc. (dba MedComp) · Gastroenterology & Urology device
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Sep 2020
Decision
30d
Days
Class 2
Risk

K202176 is an FDA 510(k) clearance for the Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Medical Components, Inc. (dba MedComp) (Harleysville, US). The FDA issued a Cleared decision on September 3, 2020 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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 Medical Components, Inc. (dba MedComp) devices

Submission Details

510(k) Number K202176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2020
Decision Date September 03, 2020
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Peers - MSD Catheter, Hemodialysis, Implanted

All 123
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K202176.
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