About This 510(k) Submission
K200320 is an FDA 510(k) clearance for the Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload, a Staple, Implantable (Class II — Special Controls, product code GDW), submitted by M/s. Meril Endo Surgery Private Limited. (Chala, Vapi, IN). The FDA issued a Cleared decision on February 5, 2021, 364 days after receiving the submission on February 7, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.