Cleared Traditional

K120702 - E.G. SCAN II ESPHAGOSCOPE SYSTEM (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K120702 · Intromedic Co., Ltd. · Ear, Nose, Throat device
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.

Submission Details

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
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 158d · This submission: 104d
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.