Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)
FDA 510(k) K253527 · Covidien, LLC
510(k) numberK253527
Submission
- Device name
- Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)
- Applicant
- Covidien, LLC
North Haven, CT, US - Received
- November 13, 2025
- Decision date
- July 1, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAG – Stapler, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4740
- Specialty
- General Hospital
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.
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| K221629 | Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters)GAG · Traditional | Covidien | 02/22/2023SE |
| K213633 | ECHELON 3000 45mm Stapler, ECHELON 3000 60mm StaplerGAG · Traditional | Ethicon Endo-Surgery, LLC | 04/08/2022SE |
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Questions and answers
When was Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) cleared by the FDA?
Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) (K253527) received a 510(k) decision of Substantially Equivalent on July 1, 2026, 230 days after the submission was received.
What is the product code of K253527?
The FDA product code is GAG – Stapler, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4740.