510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K003580Substantially Equivalent

Unitip Gastrointestinal Pressure Sensor Catheter

Unisensor AG, Golden CO / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K003580 is the FDA 510(k) clearance record for UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER, a class II device, cleared for Unisensor AG on under FDA product code FFX (System, Gastrointestinal Motility (Electrical)). FDA records list 2 510(k) clearances for Unisensor AG, from to . As of , FDA records show no recalls naming K003580.

Clearance record

Decision date
Received
(253 days to decision)
Product code
FFX System, Gastrointestinal Motility (Electrical)
Regulation
21 CFR 876.1725
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Unisensor AG 13605 W. 7th Ave., Golden CO
510(k) summary
Summary
Third party review
No

Clearances, product code FFX

Trailing 12 months
2 clearances under product code FFX in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FFX, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260