Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload— 510(k) K200320
Substantially EquivalentM/s. Meril Endo Surgery Private Limited.
FDA 510(k) clearance K200320 for Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload, Substantially Equivalent on 2021-02-05. Applicant: M/s. Meril Endo Surgery Private Limited.. Device class: 2.
Clearance details
- Applicant
- M/s. Meril Endo Surgery Private Limited.
- Product code
- Code GDW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4750
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chala, Vapi, IN
Recent devices under product code GDW
view allMore clearances from M/s. Meril Endo Surgery Private Limited.
view allAdverse events under product code GDW
product code GDW- Death
- 450
- Injury
- 12,684
- Malfunction
- 68,730
- Other
- 6
- Total
- 81,870
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.