ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)
FDA 510(k) K241629 · Ethicon Endo-Surgery, LLC
510(k) numberK241629
Submission
- Device name
- ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)
- Applicant
- Ethicon Endo-Surgery, LLC
Guaynabo, PR - Received
- June 6, 2024
- Decision date
- July 3, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K240881 | Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL…GAG · Traditional | Covidien (Part of Medtronic) | 11/01/2024SE |
| 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 |
|---|---|---|
| K260196 | ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON…GDW · Traditional | 05/11/2026SE |
| K252906 | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)OXC · Traditional | 01/09/2026SE |
| K252739 | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler…GDW · Traditional | 12/17/2025SE |
| K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler…GDW · Traditional | 05/14/2025SE |
| K243276 | ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler…GDW · Traditional | 02/25/2025SE |
| K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler…GDW · Traditional | 10/28/2024SE |
| K232313 | LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic…FZP · Special | 08/29/2023SE |
| K230387 | ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue…GEI · Traditional | 04/13/2023SE |
| K223760 | ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR…GDW · Traditional | 03/15/2023SE |
| K221790 | HARMONIC 700 ShearsLFL · Traditional | 02/28/2023SE |
Questions and answers
When was ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) cleared by the FDA?
ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) (K241629) received a 510(k) decision of Substantially Equivalent on July 3, 2024, 27 days after the submission was received.
What is the product code of K241629?
The FDA product code is GAG – Stapler, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4740.