da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
FDA 510(k) K243596 · Intuitive Surgical, Inc.
510(k) numberK243596
Submission
- Device name
- da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
- Applicant
- Intuitive Surgical, Inc.
Sunnyvale, CA, US - Received
- November 21, 2024
- Decision date
- March 10, 2025
- 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 |
| K240881 | Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL…GAG · Traditional | Covidien (Part of Medtronic) | 11/01/2024SE |
| 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 |
|---|---|---|
| K261823 | da Vinci Surgical System, Model IS5000NAY · Traditional | 09/08/2026SE |
| K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000)FDS · Traditional | 08/07/2026SE |
| K261824 | da Vinci Surgical System, Model IS5000NAY · Traditional | 07/31/2026SE |
| K261249 | Universal Seal (5-12 mm)GCJ · Traditional | 07/14/2026SE |
| K260695 | da Vinci Firefly Imaging SystemNAY · Traditional | 05/22/2026SE |
| K253986 | da Vinci Force Feedback InstrumentsNAY · Traditional | 03/11/2026SE |
| K253978 | Universal Seal (5-12 mm)GCJ · Traditional | 02/24/2026SE |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorNAY · Traditional | 01/16/2026SE |
| K251739 | da Vinci Surgical System (IS5000)NAY · Traditional | 01/16/2026SE |
| K251763 | IRISegQIH · Traditional | 12/16/2025SE |
Questions and answers
When was da Vinci SP SureForm 45 Staplers and Reloads (SP1098) cleared by the FDA?
da Vinci SP SureForm 45 Staplers and Reloads (SP1098) (K243596) received a 510(k) decision of Substantially Equivalent on March 10, 2025, 109 days after the submission was received.
What is the product code of K243596?
The FDA product code is GAG – Stapler, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4740.