Cleared Traditional

K844765 - ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN

K844765 is an FDA 510(k) clearance for ACCESSORY SET FOR CO2 LASER BRONCHOSCOP..., manufactured by Laser Spectrum, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code EWQ cleared through the Traditional 510(k) pathway after a 122-day FDA review.

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

FDA 510(k) Submission Details - K844765

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
32d slower than avg
Panel avg: 90d · This submission: 122d
Pathway characteristics
Predicate-based equivalence.

EWQ Device Classification - Class 1, General Controls

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.