Cleared Traditional

K823701 - MOTILITY CATHETERS

K823701 is an FDA 510(k) clearance for MOTILITY CATHETERS, manufactured by Mui Scientific. The device is a Class 2 Gastroenterology & Urology device with product code FFX cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K823701 · Mui Scientific · Gastroenterology & Urology device
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Feb 1983
Decision
69d
Days
Class 2
Risk

K823701 is an FDA 510(k) clearance for the MOTILITY CATHETERS. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Mui Scientific (Mississauga, Ontario, CA). The FDA issued a Cleared decision on February 15, 1983 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1725 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mui Scientific devices

FDA 510(k) Submission Details - K823701

510(k) Number K823701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1982
Decision Date February 15, 1983
Days to Decision 69 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 131d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FFX Device Classification - Class 2, Special Controls

Product Code FFX System, Gastrointestinal Motility (electrical)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FFX System, Gastrointestinal Motility (electrical)

All 53
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K823701.
AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA.
K880581 · Synectics-Dantec · Aug 1988
GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER
K874690 · Mentor Corp. · Feb 1988
SYN-02 PN AMPLIFIER
K830421 · Biosearch Medical Products, Inc. · Apr 1983
ESOPHAGEAL MOTILITY APPARATUS
K812103 · Honeywell, Inc. · Aug 1981
ESOPHAGEAL MOTILITY SYSTEM - MODEL 3330
K780812 · Honeywell, Inc. · Jun 1978
ESOPHAGEAL MOTILITY TUBE
K760761 · Sherwood Medical Industries · Nov 1976