Cleared Abbreviated

UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER (K003580) - FDA 510(k) Clearance

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

K003580 · Unisensor AG · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
253d
Days
Class 2
Risk

K003580 is an FDA 510(k) clearance for the UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Unisensor AG (Golden, US). The FDA issued a Cleared decision on July 31, 2001 after a review of 253 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1725 - the FDA gastroenterology and urology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Unisensor AG devices

Submission Details

510(k) Number K003580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2000
Decision Date July 31, 2001
Days to Decision 253 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 130d · This submission: 253d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code FFX System, Gastrointestinal Motility (electrical)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1725
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 - FFX System, Gastrointestinal Motility (electrical)

All 68
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