# K200320: Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload

- Pathway: 510(k) (Traditional)
- Applicant: M/s. Meril Endo Surgery Private Limited.
- Decided: Feb 5, 2021 after 364 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K842066 (1985). 63 ancestors in all.
No later device cites it as a predicate yet.
4 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162707: Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload, Golden Stapler Surgical Co., Ltd. (2017) Summary page 5.

## Indications for use
Mirus™ Circular Stapler has application throughout the alimentary tract for end to end, end to side and side to side anastomoses. Mirus™ Linear Cutter and Reload have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, resection, and/or creation of anastomoses. Mirus™ Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease. Mirus™ Linear Stapler and Reload has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures.

Source page: https://510kreport.com/device/K200320
Methodology: https://510kreport.com/methodology