510(k) K253527
K253527 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)". The FDA issued a decision of Substantially Equivalent on July 1, 2026. The device falls under product code GAG (Stapler, Surgical), a Class II device regulated under 21 CFR 878.4740. Covidien, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 2026
- Date Received
- November 13, 2025
- 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.