FDA 510(k), K152723, Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices

510(K) Number: K152723
Device Name: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
Manufacturer: HOLOGIC, INC
Device Classification Name: Hysteroscope (And Accessories)
Regulation Number: 884.1690
Classification Product Code: HIH
Date Received: 09/22/2015
Decision Date: 11/13/2015
Regulation Medical Specialty: Obstetrics/Gynecology

127 pages (167 of 294 original pages are fully redacted)