FDA 510(k) Applications Submitted by Hologic, Inc

FDA 510(k) Number Submission Date Device Name Applicant
K150169 01/26/2015 Sertera Biopsy Device Hologic, INC
K180233 01/29/2018 Eviva Stereotactic Guided Breast Biopsy System Hologic, Inc
K152723 09/22/2015 Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices HOLOGIC, INC
K202294 08/13/2020 Affirm Contrast Biopsy Hologic, Inc
K181974 07/24/2018 MyoSure XL Tissue Removal Device for Fluent Hologic, Inc
K182006 07/27/2018 Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths Hologic, Inc
K182052 07/31/2018 Omni Instrument Tray Hologic, Inc


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