Cleared Traditional

K924764 - OVERTUBE FOR ENDSCOPIC LIGATOR (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K924764 · Superior Healthcare Group, Inc. · Gastroenterology & Urology device
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Mar 1993
Decision
173d
Days
Class 1
Risk

K924764 is an FDA 510(k) clearance for the OVERTUBE FOR ENDSCOPIC LIGATOR. Classified as Endoscopic Bite Block (product code MNK), Class I - General Controls.

Submitted by Superior Healthcare Group, Inc. (Cumberland, US). The FDA issued a Cleared decision on March 15, 1993 after a review of 173 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Superior Healthcare Group, Inc. devices

Submission Details

510(k) Number K924764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1992
Decision Date March 15, 1993
Days to Decision 173 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 130d · This submission: 173d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MNK Endoscopic Bite Block
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1500
Definition To Prevent Patient From Biting Down In Order To Protect Fragile Endoscope Equipment, Patient's Teeth And Gums, And Endscopist's Fingers When Inserting Endoscope Orally.
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.