Cleared Traditional

K171618 - Symetrex Long Term Hemodialysis Catheter (FDA 510(k) Clearance)

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

K171618 · Medcomp (Dba Medical Components, Inc.) · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
167d
Days
Class 2
Risk

K171618 is an FDA 510(k) clearance for the Symetrex Long Term Hemodialysis Catheter. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Medcomp (Dba Medical Components, Inc.) (Harleysville, US). The FDA issued a Cleared decision on November 16, 2017 after a review of 167 days - an extended review cycle.

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.

View all Medcomp (Dba Medical Components, Inc.) devices

Submission Details

510(k) Number K171618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received June 02, 2017
Decision Date November 16, 2017
Days to Decision 167 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
37d slower than avg
Panel avg: 130d · This submission: 167d
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.

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 K171618.
Hemodialysis Catheter
K241581 · Haolang Medical USA Corporation · May 2025
End Cap
K210461 · Medical Components Inc (Medcomp) · Sep 2021
GlidePath Retro Long-Term Hemodialysis Catheter
K203575 · C.R. Bard, Inc. · Jul 2021
GlidePath 13F Long-Term Hemodialysis Catheter
K211410 · Bard Peripheral Vascular, Inc. · Jun 2021
Pristine Long-Term Hemodialysis Catheter
K203767 · C B Bard, Inc. · Apr 2021
GlidePath 7.5F Long-Term Dialysis Catheter
K202150 · C.R. Bard, Inc. · Nov 2020