Phtip Disposable Isfet Catheter

FDA 510(k) K102801 · E-Cath Co., Ltd.

Substantially Equivalent

510(k) numberK102801

Submission

Device name
Phtip Disposable Isfet Catheter
Applicant
E-Cath Co., Ltd.
Golden, CO, US
Received
September 27, 2010
Decision date
October 26, 2010
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 Phtip Disposable Isfet Catheter cleared by the FDA?

Phtip Disposable Isfet Catheter (K102801) received a 510(k) decision of Substantially Equivalent on October 26, 2010, 29 days after the submission was received.

What is the product code of K102801?

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