Cleared Traditional

K912362 - OES THORACOSCOPE SYSTEM

K912362 is an FDA 510(k) clearance for OES THORACOSCOPE SYSTEM, manufactured by Olympus Corp.. The device is a Class 2 Ear, Nose, Throat device with product code EWY cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K912362 · Olympus Corp. · Ear, Nose, Throat device
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Oct 1991
Decision
148d
Days
Class 2
Risk

K912362 is an FDA 510(k) clearance for the OES THORACOSCOPE SYSTEM. Classified as Mediastinoscope, Surgical (product code EWY), Class II - Special Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on October 24, 1991 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4720 - 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.

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FDA 510(k) Submission Details - K912362

510(k) Number K912362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1991
Decision Date October 24, 1991
Days to Decision 148 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 90d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWY Device Classification - Class 2, Special Controls

Product Code EWY Mediastinoscope, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4720
Definition 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.