Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)

Bronchoscope (flexible Or Rigid)

Intuitive Surgical, Inc.

The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Ion Endoluminal System (ion Fully Articulating Catheter), Ion Endoluminal System (ion Peripheral Vision Probe).

Pre-market Notification Details

Device IDK212048
510k NumberK212048
Device Name:Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)
ClassificationBronchoscope (flexible Or Rigid)
Applicant Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale,  CA  94086
ContactJennifer Siu
CorrespondentJennifer Siu
Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale,  CA  94086
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-30
Decision Date2021-08-26

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