The following data is part of a premarket notification filed by M/s. Meril Endo Surgery Private Limited with the FDA for Mirus Circular Stapler, Mirus Linear Cutter And Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler And Reload.
| Device ID | K200320 |
| 510k Number | K200320 |
| Device Name: | Mirus Circular Stapler, Mirus Linear Cutter And Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler And Reload |
| Classification | Staple, Implantable |
| Applicant | M/s. Meril Endo Surgery Private Limited Third Floor, E1-E3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg Chala, Vapi, IN 396191 |
| Contact | Umesh Sharma |
| Correspondent | Umesh Sharma M/s. Meril Endo Surgery Private Limited Third Floor, E1-E3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg Chala, Vapi, IN 396191 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-07 |
| Decision Date | 2021-02-05 |