MyoSure MANUAL Tissue Removal Device

Hysteroscope (and Accessories)

Hologic, Inc.

The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Myosure Manual Tissue Removal Device.

Pre-market Notification Details

Device IDK173901
510k NumberK173901
Device Name:MyoSure MANUAL Tissue Removal Device
ClassificationHysteroscope (and Accessories)
Applicant Hologic, Inc. 250 Campus Drive Marlbrough,  MA  01752
ContactAnne-marie Keefe
CorrespondentAnne-marie Keefe
Hologic, Inc. 250 Campus Drive Marlbrough,  MA  01752
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-22
Decision Date2018-05-08
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.