# K170945: Biodesign Staple Line Reinforcement

- Pathway: 510(k) (Special)
- Applicant: Cook Biotech Incorporated
- Decided: Apr 28, 2017 after 29 days
- Product code: OXE (Mesh, Surgical, Collagen, 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: 10 generations back to K842066 (1985). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070405: Modification to Surgisis SLR Staple Line Reinforcement, Cook Biotech, Inc. (2007) Summary page 4.

## Most influential descendants
- K201000: Biodesign Staple Line Reinforcement (2020), 0 descendants of its own

## Indications for use
The SURGISIS SLR Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The device may be used for buttressing and reinforcing staple lines during lung resection (e.g. wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy/pneumectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The device can be used for the reinforcement of the gastric staple line during bariatric surgical procedures of gastric bypass and gastric banding, and for reinforcement of staple lines during small bowel, mesentery, colon and colorectal procedures. The device may be used with anastomotic staplers or with non-anastomotic staplers.

Source page: https://510kreport.com/device/K170945
Methodology: https://510kreport.com/methodology