Cleared Traditional

K003830 - ENT ENDOSCOPES

K003830 is an FDA 510(k) clearance for ENT ENDOSCOPES, manufactured by Global Endoscopy, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOB cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K003830 · Global Endoscopy, Inc. · Ear, Nose, Throat device
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Apr 2001
Decision
119d
Days
Class 2
Risk

K003830 is an FDA 510(k) clearance for the ENT ENDOSCOPES. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Global Endoscopy, Inc. (Schaumburg, US). The FDA issued a Cleared decision on April 9, 2001 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4760 - 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 Global Endoscopy, Inc. devices

FDA 510(k) Submission Details - K003830

510(k) Number K003830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2000
Decision Date April 09, 2001
Days to Decision 119 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 89d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EOB Device Classification - Class 2, Special Controls

Product Code EOB Nasopharyngoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4760
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 - EOB Nasopharyngoscope (flexible Or Rigid)

All 106
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K003830.
VISION SCIENCES ENDOSHEATH SYSTEM
K012543 · Vision-Sciences, Inc. · Jul 2002
VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
K021073 · Olympus America, Inc. · May 2002
KSEA CLEARVISION LENS IRRIGATION SYSTEM
K013838 · KARL STORZ Endoscopy-America, Inc. · Jan 2002
KSEA UNIMAT 12
K002700 · KARL STORZ Endoscopy-America, Inc. · Oct 2000
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE
K992526 · Richard Wolf Medical Instruments Corp. · Sep 1999
ENDOSHEATH
K990354 · Vision-Sciences, Inc. · Mar 1999