510(k) K240881
K240881 is an FDA 510(k) premarket notification submitted by Covidien (Part of Medtronic) for the device "Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL)". The FDA issued a decision of Substantially Equivalent on November 1, 2024. The device falls under product code GAG (Stapler, Surgical), a Class II device regulated under 21 CFR 878.4740. Covidien (Part of Medtronic) has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 2024
- Date Received
- April 1, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stapler, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4740
- Review Panel
- SU
- Submission Type
A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.