Cleared Traditional

GASTROGRAPH (K903646) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K903646 · Medics Instrument Corp. · Gastroenterology & Urology device
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Nov 1990
Decision
83d
Days
Class 1
Risk

K903646 is an FDA 510(k) clearance for the GASTROGRAPH. Classified as Electrode, Ph, Stomach (product code FFT), Class I - General Controls.

Submitted by Medics Instrument Corp. (Friedhofplatz 16 , West, DE). The FDA issued a Cleared decision on November 5, 1990 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1400 - 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 Medics Instrument Corp. devices

Submission Details

510(k) Number K903646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1990
Decision Date November 05, 1990
Days to Decision 83 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
47d faster than avg
Panel avg: 130d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FFT Electrode, Ph, Stomach
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1400
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.