Cleared Traditional

K111030 - E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM

K111030 is an FDA 510(k) clearance for E.G. SCAN (TM) ESOPHAGOSCOPE 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 191-day FDA review.

K111030 · Intromedic Co., Ltd. · Ear, Nose, Throat device
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Oct 2011
Decision
191d
Days
Class 2
Risk

K111030 is an FDA 510(k) clearance for the E.G. SCAN (TM) ESOPHAGOSCOPE 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 October 21, 2011 after a review of 191 days - an extended review 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. 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 - K111030

510(k) Number K111030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2011
Decision Date October 21, 2011
Days to Decision 191 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
101d slower than avg
Panel avg: 90d · This submission: 191d
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.

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 K111030.
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 II ESPHAGOSCOPE SYSTEM
K120702 · Intromedic Co., Ltd. · Jun 2012
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
KARL STORZ TRANS-NASAL ESOPHAGOSCOPE
K051972 · KARL STORZ Endoscopy-America, Inc. · Aug 2005

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.