Cleared Traditional

TREBAY MICRODEBRIDER SYSTEM (K955704) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K955704 · Trebay Medical Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
46d
Days
Class 1
Risk

K955704 is an FDA 510(k) clearance for the TREBAY MICRODEBRIDER SYSTEM. Classified as Bur, Ear, Nose And Throat (product code EQJ), Class I - General Controls.

Submitted by Trebay Medical Corp. (Clearwater, US). The FDA issued a Cleared decision on January 30, 1996 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4140 - the FDA ear, nose and throat 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 Trebay Medical Corp. devices

Submission Details

510(k) Number K955704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1995
Decision Date January 30, 1996
Days to Decision 46 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 89d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EQJ Bur, Ear, Nose And Throat
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4140
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.

Regulatory Peers - EQJ Bur, Ear, Nose And Throat

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K946332 · KARL STORZ Endoscopy-America, Inc. · Jun 1995