510(k) K200320

Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload by M/s. Meril Endo Surgery Private Limited. — Product Code GDW

K200320 is an FDA 510(k) premarket notification submitted by M/s. Meril Endo Surgery Private Limited. for the device "Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload". The FDA issued a decision of Substantially Equivalent on February 5, 2021. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. M/s. Meril Endo Surgery Private Limited. has at least 10 other 510(k) clearances on record.