Cleared Traditional

K171291 - FUJIFILM Bronchoscope Model EB-530P

K171291 is the FDA 510(k) clearance for FUJIFILM Bronchoscope Model EB-530P by Fujifilm Medical Systems U.S.A, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOQ) cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K171291 · Fujifilm Medical Systems U.S.A, Inc. · Ear, Nose, Throat device
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Jan 2018
Decision
262d
Days
Class 2
Risk

K171291 is an FDA 510(k) clearance for the FUJIFILM Bronchoscope Model EB-530P. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Fujifilm Medical Systems U.S.A, Inc. (Wayne, US). The FDA issued a Cleared decision on January 19, 2018 after a review of 262 days - an extended review 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. 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 Fujifilm Medical Systems U.S.A, Inc. devices

Submission Details

510(k) Number K171291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2017
Decision Date January 19, 2018
Days to Decision 262 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 89d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 182
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K171291.
Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2
K173727 · Ambu A/S · Mar 2018
Monarch Endoscopy Platform (Monarch Platform)
K173760 · Auris Surgical Robotics, Inc. · Mar 2018
Captura Disposable Bronchoscope Biopsy Forceps
K163377 · Wilson-Cook Medical, Inc. · Feb 2018
PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope
K173554 · Pentax of America, Inc. · Jan 2018
Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
K163537 · Covidien, LLC · Apr 2017
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K163248 · Boston Scientific Corporation · Mar 2017