Cleared Traditional

K013160 - POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEM...

K013160 is an FDA 510(k) clearance for POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEM..., manufactured by Spire Biomedical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K013160 · Spire Biomedical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
202d
Days
Class 2
Risk

K013160 is an FDA 510(k) clearance for the POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Spire Biomedical, Inc. (Bedford, US). The FDA issued a Cleared decision on April 11, 2002 after a review of 202 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 Spire Biomedical, Inc. devices

FDA 510(k) Submission Details - K013160

510(k) Number K013160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2001
Decision Date April 11, 2002
Days to Decision 202 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
72d slower than avg
Panel avg: 130d · This submission: 202d
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 64
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