Standard Staple-Line Reinforcement (SSLR23)
FDA 510(k) K231603 · Standard Bariatrics, Inc.
510(k) numberK231603
Submission
- Device name
- Standard Staple-Line Reinforcement (SSLR23)
- Applicant
- Standard Bariatrics, Inc.
Cincinnati, OH, US - Received
- June 1, 2023
- Decision date
- October 6, 2023
- 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 |
| 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 |
| 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 |
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| K181608 | Disposable Standard ClampGCJ · Traditional | 09/27/2018SE |
| K170379 | Disposable Standard ClampGCJ · Traditional | 07/19/2017SE |
| K161720 | Standard ClampGCJ · Traditional | 10/24/2016SE |
Questions and answers
When was Standard Staple-Line Reinforcement (SSLR23) cleared by the FDA?
Standard Staple-Line Reinforcement (SSLR23) (K231603) received a 510(k) decision of Substantially Equivalent on October 6, 2023, 127 days after the submission was received.
What is the product code of K231603?
The FDA product code is OXC – Mesh, Surgical, Absorbable, Staple Line Reinforcement, a Class II (moderate risk) device regulated under 21 CFR 878.3300.