Cleared Traditional

ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN (K844765) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K844765 · Laser Spectrum, Inc. · Ear, Nose, Throat device
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Apr 1985
Decision
122d
Days
Class 1
Risk

K844765 is an FDA 510(k) clearance for the ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN. Classified as Saw, Surgical, Ent (electric Or Pneumatic) (product code EWQ), Class I - General Controls.

Submitted by Laser Spectrum, Inc. (Chicago, US). The FDA issued a Cleared decision on April 8, 1985 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - 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 Laser Spectrum, Inc. devices

Submission Details

510(k) Number K844765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1984
Decision Date April 08, 1985
Days to Decision 122 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
33d slower than avg
Panel avg: 89d · This submission: 122d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EWQ Saw, Surgical, Ent (electric Or Pneumatic)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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.