FDA 510(k), K181974, MyoSure XL Tissue Removal Device for Fluent

510(K) Number: K181974
Device Name: MyoSure XL Tissue Removal Device for Fluent
Manufacturer: Hologic, Inc
Device Classification Name: Hysteroscope (And Accessories)
Regulation Number: 884.1690
Classification Product Code: HIH
Date Received: 07/24/2018
Decision Date: 08/23/2018
Regulation Medical Specialty: Obstetrics/Gynecology

130 pages (54 of 184 original pages are fully redacted)