Motility Catheters

FDA 510(k) K823701 · Mui Scientific

Substantially Equivalent

510(k) numberK823701

Submission

Device name
Motility Catheters
Applicant
Mui Scientific
Mississauga, Ontario, CA
Received
December 8, 1982
Decision date
February 15, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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 Motility Catheters cleared by the FDA?

Motility Catheters (K823701) received a 510(k) decision of Substantially Equivalent on February 15, 1983, 69 days after the submission was received.

What is the product code of K823701?

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