# K201000: Biodesign Staple Line Reinforcement

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech Incorporated
- Decided: Jul 13, 2020 after 88 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: 11 generations back to K842066 (1985). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170945: Biodesign Staple Line Reinforcement, Cook Biotech Incorporated (2017) Summary page 4.

## Indications for use
The Biodesign® Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The Staple Line Reinforcement 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 Staple Line Reinforcement can be used for the reinforcement of the gastric staple line during bariatric surgical procedures, and for reinforcement of staple lines during small bowel, mesentery, colon and colorectal procedures. The Staple Line Reinforcement may be used with anastomotic staplers or with non-anastomotic staplers.

Source page: https://510kreport.com/device/K201000
Methodology: https://510kreport.com/methodology