Unitip High Resolution Catheter

FDA 510(k) K062222 · Unisensor AG

Substantially Equivalent

510(k) numberK062222

Submission

Device name
Unitip High Resolution Catheter
Applicant
Unisensor AG
Golden, CO, US
Received
August 2, 2006
Decision date
March 15, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FFX – System, Gastrointestinal Motility (Electrical)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1725
Specialty
Gastroenterology, Urology

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Questions and answers

When was Unitip High Resolution Catheter cleared by the FDA?

Unitip High Resolution Catheter (K062222) received a 510(k) decision of Substantially Equivalent on March 15, 2007, 225 days after the submission was received.

What is the product code of K062222?

The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.