Cleared Traditional

K770754 - DUODENOSCOPE, MOLEL TX-6 (FDA 510(k) Clearance)

Class I Anesthesiology device.

K770754 · American Cystocope Makers, Inc. · Anesthesiology device
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Apr 1977
Decision
3d
Days
Class 1
Risk

K770754 is an FDA 510(k) clearance for the DUODENOSCOPE, MOLEL TX-6. Classified as Hood, Oxygen, Infant (product code FOG), Class I - General Controls.

Submitted by American Cystocope Makers, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 28, 1977 after a review of 3 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5700 - the FDA anesthesiology and respiratory 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 American Cystocope Makers, Inc. devices

Submission Details

510(k) Number K770754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1977
Decision Date April 28, 1977
Days to Decision 3 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d faster than avg
Panel avg: 139d · This submission: 3d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FOG Hood, Oxygen, Infant
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5700
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.