Cleared Traditional

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

K111030 is the FDA 510(k) clearance for E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM by Intromedic Co., Ltd.. It is a Class 2 Ear, Nose, Throat device (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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Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 89d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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.

Regulatory Peers - EOX Esophagoscope (flexible Or Rigid)

All 23
Devices cleared under the same product code (EOX) and FDA review panel - the closest regulatory comparables to K111030.
Cytosponge Cell Collection Device
K181020 · Covidien, LLC · Aug 2018
Cytosponge Cell Collection Device
K152794 · Covidien, LLC · Apr 2016
Cytosponge Cell Collection Device
K142695 · Covidien, LLC · Nov 2014
KARL STORZ TRANS-NASAL ESOPHAGOSCOPE
K051972 · KARL STORZ Endoscopy-America, Inc. · Aug 2005
PRISM ELECTROSCOPE
K953849 · KARL STORZ Endoscopy-America, Inc. · Sep 1995
KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES
K951395 · KARL STORZ Endoscopy-America, Inc. · May 1995