Endoscope Sterilization Tray

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Intuitive Surgical, Inc.

The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Endoscope Sterilization Tray.

Pre-market Notification Details

Device IDK170640
510k NumberK170640
Device Name:Endoscope Sterilization Tray
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant Intuitive Surgical, Inc. 1266 Kifer Road Building 101 Sunnyvale,  CA  94086
ContactKunal Gunjal
CorrespondentKunal Gunjal
Intuitive Surgical, Inc. 1266 Kifer Road Building 101 Sunnyvale,  CA  94086
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-02
Decision Date2017-09-17
Summary:summary

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