Ion Endoluminal System

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.

Pre-market Notification Details

Device IDK201146
510k NumberK201146
Device Name:Ion Endoluminal System
ClassificationBronchoscope (flexible Or Rigid)
Applicant Intuitive Surgical, Inc. 1266 Kifer Rd. Sunnyvale,  CA  94086
ContactJennifer Siu
CorrespondentJennifer Siu
Intuitive Surgical, Inc. 1266 Kifer Rd. Sunnyvale,  CA  94086
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-29
Decision Date2020-06-26

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