Cleared Traditional

K010306 - MEDCOMP EXCELL SPLIT TIP CATHETER

K010306 is an FDA 510(k) clearance for MEDCOMP EXCELL SPLIT TIP CATHETER, manufactured by Medcomp. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K010306 · Medcomp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Oct 2001
Decision
244d
Days
Class 2
Risk

K010306 is an FDA 510(k) clearance for the MEDCOMP EXCELL SPLIT TIP CATHETER. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Medcomp (Harleysville, US). The FDA issued a Cleared decision on October 3, 2001 after a review of 244 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 devices

FDA 510(k) Submission Details - K010306

510(k) Number K010306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2001
Decision Date October 03, 2001
Days to Decision 244 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
113d slower than avg
Panel avg: 131d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSD Device Classification - Class 2, Special Controls

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 83
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K010306.
POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER
K013160 · Spire Biomedical, Inc. · Apr 2002
MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER
K012562 · Medical Components, Inc. · Feb 2002
SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES
K011916 · Horizon Medical Products, Inc. · Oct 2001
HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40
K994105 · Medical Components, Inc. · Oct 2001
VAXCEL DIALYSIS CATHETER
K012365 · Boston Scientific Corp · Aug 2001
MEDCOMP ULTRA-FLOW CATHETER
K003207 · Medical Components, Inc. · Jun 2001