Echelon Endopath Staple Line Reinforcement
FDA 510(k) K190937 · Ethicon Endo-Surgery, LLC
510(k) numberK190937
Submission
- Device name
- Echelon Endopath Staple Line Reinforcement
- Applicant
- Ethicon Endo-Surgery, LLC
Guaynabo, PR, US - Received
- April 10, 2019
- Decision date
- October 14, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OXC – Mesh, Surgical, Absorbable, Staple Line Reinforcement
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.
Other 510(k)s with product code OXC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252906 | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)OXC · Traditional | Ethicon Endo-Surgery, LLC | 01/09/2026SE |
| K231603 | Standard Staple-Line Reinforcement (SSLR23)OXC · Traditional | Standard Bariatrics, Inc. | 10/06/2023SE |
| K221343 | ECHELON ENDOPATH Staple Line ReinforcementOXC · Traditional | Ethicon Endo-Surgery, LLC | 09/16/2022SE |
| K221487 | NEOVEIL Staple Line ReinforcementOXC · Special | Gunze Limited | 08/26/2022SE |
| K181940 | GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementOXC · Special | W. L. Gore & Associates, Inc. | 08/17/2018SE |
| K150551 | GORE SEAMGUARD ReinforcementOXC · Special | W. L. Gore & Associates, Inc. | 03/30/2015SE |
| K130997 | NeoveilOXC · Traditional | Gunze Limited | 11/15/2013SE |
| K131658 | Gore Seamguard ReinforcementOXC · Traditional | W. L. Gore & Associates, Inc. | 09/06/2013SE |
More from W. L. Gore & Associates, Inc.
| 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 |
| K241629 | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S)…GAG · Special | 07/03/2024SE |
| 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 |
Questions and answers
When was Echelon Endopath Staple Line Reinforcement cleared by the FDA?
Echelon Endopath Staple Line Reinforcement (K190937) received a 510(k) decision of Substantially Equivalent on October 14, 2019, 187 days after the submission was received.
What is the product code of K190937?
The FDA product code is OXC – Mesh, Surgical, Absorbable, Staple Line Reinforcement, a Class II (moderate risk) device regulated under 21 CFR 878.3300.