Cleared Traditional

K120702 - E.G. SCAN II ESPHAGOSCOPE SYSTEM

K120702 is an FDA 510(k) clearance for E.G. SCAN II ESPHAGOSCOPE SYSTEM, manufactured by Intromedic Co., Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code EOX cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K120702 · Intromedic Co., Ltd. · Ear, Nose, Throat device
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Jun 2012
Decision
104d
Days
Class 2
Risk

K120702 is an FDA 510(k) clearance for the E.G. SCAN II ESPHAGOSCOPE SYSTEM. Classified as Esophagoscope (flexible Or Rigid) (product code EOX), Class II - Special Controls.

Submitted by Intromedic Co., Ltd. (Guro-Gu , Seoul, KR). The FDA issued a Cleared decision on June 20, 2012 after a review of 104 days - within the typical 510(k) review window.

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. 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 Intromedic Co., Ltd. devices

FDA 510(k) Submission Details - K120702

510(k) Number K120702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2012
Decision Date June 20, 2012
Days to Decision 104 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 90d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

EOX Device Classification - Class 2, Special Controls

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.

Regulatory Consultant

Underwriters Laboratories, Inc.
MARC M MOUSER

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EOX Esophagoscope (flexible Or Rigid)

All 28
Devices cleared under the same product code (EOX) and FDA review panel - the closest regulatory comparables to K120702.
Cytosponge Cell Collection Device
K152794 · Covidien, LLC · Apr 2016
Cytosponge Cell Collection Device
K142695 · Covidien, LLC · Nov 2014
E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM
K131131 · Intromedic Co., Ltd. · Jun 2013
E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM
K111030 · Intromedic Co., Ltd. · Oct 2011
FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS
K072088 · Vision-Sciences, Inc. · Aug 2007
ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE
K071903 · Vision-Sciences, Inc. · Aug 2007

FDA 510(k) Resources - Ear, Nose, Throat

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.