UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER— 510(k) K003580

Name: FDA 510(k) clearance K003580
Creator: U.S. Food and Drug Administration
Published: 2001-07-31

Substantially Equivalent

Unisensor AG

FDA 510(k) clearance K003580 for UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER, Substantially Equivalent on 2001-07-31. Applicant: Unisensor AG. Device class: 2.

Clearance details

Applicant: Unisensor AG
Product code: Product code FFX
Device class: Class 2
Regulation: 21 CFR 876.1725
Advisory panel: Gastroenterology, Urology
Date received: 2000-11-20
Decision date: 2001-07-31
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Golden, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FFX

product code FFX

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.