510(k) K201756

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 by Stryker Sustainability Solutions — Product Code HIH

K201756 is an FDA 510(k) premarket notification submitted by Stryker Sustainability Solutions for the device "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". The FDA issued a decision of Substantially Equivalent on September 25, 2020. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Stryker Sustainability Solutions has at least 10 other 510(k) clearances on record.