Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Ion Endoluminal System

K-Number: K192367 · 2019-11-26

ApplicantIntuitive Surgical, Inc.
Decision Date2019-11-26
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Ion Endoluminal System is a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2019-11-26 under approval number K192367. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ion Endoluminal System?

Ion Endoluminal System is a medical device that received FDA 510(k) clearance on 2019-11-26. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K192367.

When was Ion Endoluminal System approved by the FDA?

Ion Endoluminal System received FDA 510(k) clearance on 2019-11-26, under approval number K192367.

What company makes Ion Endoluminal System?

Ion Endoluminal System is manufactured by Intuitive Surgical, Inc..

What is the FDA product code for Ion Endoluminal System?

The FDA product code for Ion Endoluminal System is EOQ.

Related Clinical Trials

NCT06004440 Real World Registry for Use of the Ion Endoluminal System ACTIVE_NOT_RECRUITING NCT06133387 PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System RECRUITING NCT06308120 A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB ACTIVE_NOT_RECRUITING

Other Devices by Intuitive Surgical, Inc.

K162411da Vinci Xi 12 – 8 mm Reducer K153276da Vinci Xi Surgical System K161271da Vinci Xi Surgical System K152578da Vinci Surgical System, Model IS4000 K152448da Vinci Single-Site Instrument and Accessories K152421IS4000 Stapler 30 Instrument and Stapler 30 Reloads

View all 107 devices →

Related Devices (Code: EOQ)

K161656Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView MonitorAmbu A/S K152319Auris Robotic Endoscopy System (ARES)Auris Surgical Robotics, Inc. K152466Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)Prosurg, Inc. K171492B7 2C Occlusion BalloonSpiration, Inc. K163537Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaCovidien, LLC K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑