Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device For Fluent

Hysteroscope (and Accessories)

Stryker Sustainability Solutions

The following data is part of a premarket notification filed by Stryker Sustainability Solutions with the FDA for Reprocessed Myosure Tissue Removal Device, Reprocessed Myosure Reach Tissue Removal Device, Reprocessed Myosure Lite Tissue Removal Device, Reprocessed Myosure Xl Tissue Removal Device, Reprocessed Myosure Xl Tissue Removal Device For Fluent.

Pre-market Notification Details

Device IDK201756
510k NumberK201756
Device Name:Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device For Fluent
ClassificationHysteroscope (and Accessories)
Applicant Stryker Sustainability Solutions 1810 W Drake Drive Tempe,  AZ  85283
ContactScott English
CorrespondentScott English
Stryker Sustainability Solutions 1810 W Drake Drive Tempe,  AZ  85283
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-29
Decision Date2020-09-25

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