Cleared Special

K131131 - E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K131131 · Intromedic Co., Ltd. · Ear, Nose, Throat device
Jun 2013
Decision
60d
Days
Class 2
Risk

K131131 is an FDA 510(k) clearance for the E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM. Classified as Esophagoscope (flexible Or Rigid) (product code EOX), Class II - Special Controls.

Submitted by Intromedic Co., Ltd. (Los Angeles, US). The FDA issued a Cleared decision on June 21, 2013 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4710 - the FDA ear, nose and throat device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K131131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2013
Decision Date June 21, 2013
Days to Decision 60 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 158d · This submission: 60d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code EOX Esophagoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4710
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.