Cleared Traditional

Ion Endoluminal System (K182188) - FDA 510(k) Clearance

Also marketed or referenced as:
Flexision Biopsy Needle

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

K182188 · Intuitive Surgical · Ear, Nose, Throat device
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Feb 2019
Decision
185d
Days
Class 2
Risk

K182188 is an FDA 510(k) clearance for the Ion Endoluminal System. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Intuitive Surgical (Sunnyvale, US). The FDA issued a Cleared decision on February 14, 2019 after a review of 185 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 Intuitive Surgical devices

Submission Details

510(k) Number K182188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2018
Decision Date February 14, 2019
Days to Decision 185 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
96d slower than avg
Panel avg: 89d · This submission: 185d
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 136
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K182188.
FUJIFILM Video Bronchoscopes
K182253 · Fujifilm Corporation · Apr 2019
CoreDx™ Pulmonary Mini-Forceps
K183085 · Boston Scientific Corporation · Mar 2019
FUJIFILM Ultrasonic Endoscope
K182825 · Fujifilm Corporation · Feb 2019
GlideScope BFlex Single-Use Bronchoscope System
K183256 · Verathon Medical (Canada) Ulc · Jan 2019
EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D
K172726 · Olympus Medical Systems Corp. · Apr 2018
LungVision Tool
K172955 · Bodyvision Medical , Ltd. · Apr 2018