Cleared Traditional

K192367 - Ion Endoluminal System

K192367 is the FDA 510(k) clearance for Ion Endoluminal System by Intuitive Surgical, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOQ) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K192367 · Intuitive Surgical, Inc. · Ear, Nose, Throat device
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Nov 2019
Decision
88d
Days
Class 2
Risk

K192367 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, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 26, 2019 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intuitive Surgical, Inc. devices

Submission Details

510(k) Number K192367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2019
Decision Date November 26, 2019
Days to Decision 88 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
1d faster than avg
Panel avg: 89d · This submission: 88d
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 176
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K192367.
Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR
K192164 · Olympus Medical Systems Corp. · Mar 2020
Vathin Video Bronchoscope System
K191828 · Hunan Vathin Medical Instrument Co., Ltd. · Feb 2020
GlideScope BFlex 3.8 Single-Use Bronchoscope
K193488 · Verathon Medical (Canada) Ulc · Jan 2020
PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
K183516 · Pentax of America, Inc. · Sep 2019
EVIS EXERA III Bronchovideoscope Olympus BF-XT190
K183419 · Olympus Medical Systems Corp. · Sep 2019
FUJIFILM Bronchoscope
K183607 · Fujifilm Corporation · Aug 2019