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Motility Catheters

by Mui Scientific

510(k) K823701

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK823701 Date15 Feb 1983ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FFX
Device Class
Class II
Regulation
21 CFR Part 876.1725
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Motility Catheters are designed as part of a System, Gastrointestinal Motility (Electrical) per FDA nomenclature, used for assessing gastrointestinal motility through electrical measurements. These catheters facilitate the evaluation of muscle contractions and functional dynamics within the digestive tract, aiding in the diagnosis of motility disorders.

Supplied as single-use devices, these catheters are manufactured from medical-grade polyvinyl chloride (PVC) tubing and undergo precision quality testing. They are intended for use in clinical and research settings within gastroenterology and urology, with multiple reference codes (e.g., 3010381606, 3002807135) for regulatory tracking. The devices fall under FDA classification 2 and are authorized via FDA 510K clearance (K823701) under regulation 876.1725.

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