Cleared Abbreviated

K003580 - UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER

K003580 is an FDA 510(k) clearance for UNITIP GASTROINTESTINAL PRESSURE SENSOR..., manufactured by Unisensor AG. The device is a Class 2 Gastroenterology & Urology device with product code FFX cleared through the Abbreviated 510(k) pathway after a 253-day FDA review.

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

FDA 510(k) Submission Details - K003580

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
122d slower than avg
Panel avg: 131d · This submission: 253d
Pathway characteristics
Standards-based clearance path.

FFX Device Classification - Class 2, Special Controls

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 53
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K003580.
OHMEGA
K060166 · Medical Measurement Systems B.V. · Apr 2006
SOLAR GI
K052338 · Medical Measurement Systems B.V. · Dec 2005
INSIGHT, MODEL S980000
K012232 · Sandhill Scientific, Inc. · Jun 2002
SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026
K002427 · Sandhill Scientific, Inc. · Jun 2001
POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101
K992713 · Medtronic Functional Diagnostics A/S · Nov 1999
ANORECTAL MANOMETRY SUITE, MODEL 9032S0201
K991389 · Medtronic Functional Diagnostics A/S · Jul 1999