# K231603: Standard Staple-Line Reinforcement (SSLR23)

- Pathway: 510(k) (Traditional)
- Applicant: Standard Bariatrics, Inc.
- Decided: Oct 6, 2023 after 127 days
- Product code: OXC (Mesh, Surgical, Absorbable, Staple Line Reinforcement)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K842066 (1985). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181940: GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement, W. L. Gore & Associates, Inc. (2018) Summary page 5.

## Indications for use
Standard Staple-Line Reinforcement is indicated for use in bariatric procedures in which gastric tissue transection and resection with staple line reinforcement is needed.

Source page: https://510kreport.com/device/K231603
Methodology: https://510kreport.com/methodology