Esophageal Motility Tube

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K760761 ↗

FDA Product Code

FFX

Device Class

Class II

Regulation

21 CFR Part 876.1725

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K771052 Active Cleared 27 Jun 1977

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• Reagent Kit, Lancer Glucose

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• What is the Esophageal Motility Tube used for?

  The Esophageal Motility Tube is used to measure esophageal motility in the field of gastroenterology and urology.

• How is the Esophageal Motility Tube supplied?

  The Esophageal Motility Tube is supplied as a single device, intended for use in a clinical setting.

• What is the regulatory classification of the Esophageal Motility Tube?

  The Esophageal Motility Tube is classified as a System, Gastrointestinal Motility (Electrical) device, regulated under regulation number 876.1725 with a product code of FFX.

• Is the Esophageal Motility Tube cleared by the FDA?

  Yes, the Esophageal Motility Tube has been cleared by the FDA under the traditional 510(k) clearance process, with the decision code SESE.