Resectr Tissue Resection Device

Hysteroscope (and Accessories)

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Resectr Tissue Resection Device.

Pre-market Notification Details

Device IDK191538
510k NumberK191538
Device Name:Resectr Tissue Resection Device
ClassificationHysteroscope (and Accessories)
Applicant Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
ContactBrooke Cuddy
CorrespondentBrooke Cuddy
Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyObstetrics/Gynecology
510k Review PanelObstetrics/Gynecology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-10
Decision Date2020-01-16

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