Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL)
FDA 510(k) K240881 · Covidien (Part of Medtronic)
510(k) numberK240881
Submission
- Device name
- Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL)
- Applicant
- Covidien (Part of Medtronic)
North Haven, CT, US - Received
- April 1, 2024
- Decision date
- November 1, 2024
- 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.
Other 510(k)s with product code GAG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253527 | Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0…GAG · Traditional | Covidien, LLC | 07/01/2026SE |
| K251482 | AEON Endoscopic Powered StaplerGAG · Traditional | Lexington Medical, Inc. | 07/11/2025SE |
| K243596 | da Vinci SP SureForm 45 Staplers and Reloads (SP1098)GAG · Traditional | Intuitive Surgical, Inc. | 03/10/2025SE |
| K241629 | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S)…GAG · Special | Ethicon Endo-Surgery, LLC | 07/03/2024SE |
| K234039 | AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler…GAG · Traditional | Lexington Medical, Inc. | 05/07/2024SE |
| K231934 | GIA Stapler with Tri-Staple TechnologyGAG · Traditional | Covidien | 10/27/2023SE |
| K232126 | EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular Stapler…GAG · Special | Covidien | 08/16/2023SE |
| K231491 | TA Stapler and Loading Unit with DST Series TechnologyGAG · Traditional | Covidien | 08/16/2023SE |
| 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 |
More from Ethicon Endo-Surgery, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K253657 | Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray…GDW · Traditional | 04/10/2026SE |
Questions and answers
When was Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL) cleared by the FDA?
Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL) (K240881) received a 510(k) decision of Substantially Equivalent on November 1, 2024, 214 days after the submission was received.
What is the product code of K240881?
The FDA product code is GAG – Stapler, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4740.