Cleared Special

EB-1830T3, VIDEO BRONCHOSCOPE (K023376) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K023376 · Pentax Precision Instrument Corp. · Ear, Nose, Throat device
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Oct 2002
Decision
8d
Days
Class 2
Risk

K023376 is an FDA 510(k) clearance for the EB-1830T3, VIDEO BRONCHOSCOPE. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Pentax Precision Instrument Corp. (Orangeburg, US). The FDA issued a Cleared decision on October 16, 2002 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4680 - the FDA ear, nose and throat device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pentax Precision Instrument Corp. devices

Submission Details

510(k) Number K023376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2002
Decision Date October 16, 2002
Days to Decision 8 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 89d · This submission: 8d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code EOQ Bronchoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. 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 - EOQ Bronchoscope (flexible Or Rigid)

All 120
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K023376.
KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM
K071530 · KARL STORZ Endoscopy-America, Inc. · Aug 2007
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
K040018 · Boston Scientific Corp · Jan 2004
ENK FIBEROPTIC ATOMIZER SET
K031966 · Cook, Inc. · Oct 2003
TBAN
K963252 · Boston Scientific Corp · Sep 1996
KARL STORZ INTUBATION FIBERSCOPE
K961178 · KARL STORZ Endoscopy-America, Inc. · May 1996
KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS
K960791 · KARL STORZ Endoscopy-America, Inc. · Mar 1996