# K070405: Modification to Surgisis SLR Staple Line Reinforcement

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: Oct 17, 2007 after 247 days
- Product code: FTM (Mesh, Surgical)
- 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). 29 ancestors in all.
2 later devices descend 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)
- K051048: Surgisis Staple Line Reinforcement II, Cook Biotech, Inc. (2005) Summary page 4.

## Most influential descendants
- K170945: Biodesign Staple Line Reinforcement (2017), 1 descendant of its own
- 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 the 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. The device is supplied sterile and is intended for one-time use.

Source page: https://510kreport.com/device/K070405
Methodology: https://510kreport.com/methodology