Ion Endoluminal System (IF1000)

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 (if1000).

Pre-market Notification Details

Device IDK220299
510k NumberK220299
Device Name:Ion Endoluminal System (IF1000)
ClassificationBronchoscope (flexible Or Rigid)
Applicant Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale,  CA  94086
ContactJyoti Singh
CorrespondentJyoti Singh
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 Received2022-02-02
Decision Date2022-06-16

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