Cleared Traditional

K864387 - LUXTEC FIBEROPTIC CABLES (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K864387 · Luxtec Corp. · Ear, Nose, Throat device
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May 1987
Decision
198d
Days
Class 1
Risk

K864387 is an FDA 510(k) clearance for the LUXTEC FIBEROPTIC CABLES. Classified as Source, Carrier, Fiberoptic Light (product code EQH), Class I - General Controls.

Submitted by Luxtec Corp. (Sturbridge, US). The FDA issued a Cleared decision on May 22, 1987 after a review of 198 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4350 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Luxtec Corp. devices

Submission Details

510(k) Number K864387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1986
Decision Date May 22, 1987
Days to Decision 198 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 89d · This submission: 198d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EQH Source, Carrier, Fiberoptic Light
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4350
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.