Cleared Traditional

K862835 - CO2 FIBEROPTIC DELIVERY SYSTEM/BRONCHOS...

K862835 is an FDA 510(k) clearance for CO2 FIBEROPTIC DELIVERY SYSTEM/BRONCHOS..., manufactured by Cooper Lasersonics, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOQ cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K862835 · Cooper Lasersonics, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Feb 1987
Decision
195d
Days
Class 2
Risk

K862835 is an FDA 510(k) clearance for the CO2 FIBEROPTIC DELIVERY SYSTEM/BRONCHOSCOPIC USE. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Cooper Lasersonics, Inc. (Santa Clara, US). The FDA issued a Cleared decision on February 5, 1987 after a review of 195 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4680 - 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 Cooper Lasersonics, Inc. devices

FDA 510(k) Submission Details - K862835

510(k) Number K862835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1986
Decision Date February 05, 1987
Days to Decision 195 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 89d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EOQ Device Classification - Class 2, Special Controls

Product Code EOQ Bronchoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EOQ Bronchoscope (flexible Or Rigid)

All 187
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K862835.
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