GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement
FDA 510(k) K181940 · W. L. Gore & Associates, Inc.
510(k) numberK181940
Submission
- Device name
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement
- Applicant
- W. L. Gore & Associates, Inc.
Elkton, MD, US - Received
- July 19, 2018
- Decision date
- August 17, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K190937 | Echelon Endopath Staple Line ReinforcementOXC · Traditional | Ethicon Endo-Surgery, LLC | 10/14/2019SE |
| 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 |
|---|---|---|
| K250410 | GORE® Tri-Lobe Balloon CatheterDQY · Traditional | 06/02/2025SE |
| K240083 | GORE® PROPATEN® Vascular GraftDSY · Traditional | 03/01/2024SE |
| K232312 | GORE® PROPATEN® Vascular GraftDSY · Traditional | 01/09/2024SE |
| K233551 | GORE® ACUSEAL Vascular GraftDSY · Traditional | 12/19/2023SE |
| K231505 | GORE® ACUSEAL Vascular GraftDSY · Special | 06/23/2023SE |
| K191773 | GORE BIO-A Tissue ReinforcementOWT · Special | 07/31/2019SE |
| K173333 | GORE ENFORM BiomaterialOXF · Traditional | 04/05/2018SE |
| K163576 | GORE SYNECOR Preperitoneal BiomaterialFTL · Traditional | 05/11/2017SE |
| K170740 | GORE VIABIL Short Wire Biliary EndoprosthesisFGE · Traditional | 05/08/2017SESU |
| K163217 | GORE BIO-A Tissue ReinforcementOXF · Traditional | 02/10/2017SE |
Questions and answers
When was GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement cleared by the FDA?
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (K181940) received a 510(k) decision of Substantially Equivalent on August 17, 2018, 29 days after the submission was received.
What is the product code of K181940?
The FDA product code is OXC – Mesh, Surgical, Absorbable, Staple Line Reinforcement, a Class II (moderate risk) device regulated under 21 CFR 878.3300.