# K051048: Surgisis Staple Line Reinforcement II

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: Sep 23, 2005 after 151 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: 8 generations back to K842066 (1985). 28 ancestors in all.
3 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)
- K022044: Surgisis Staple Line Reinforcement, Cook Biotech, Inc. (2002) Summary page 1.
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 1.
- K040119: Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line Reinforcement-Strip Configuration, Synovis Surgical Innovations (2004) Summary page 1.
- K032865: Gore Seamguard Bioabsorbable Staple Line Reinforcement Material, W. L. Gore & Associates, Inc. (2003) Summary page 1.

## Most influential descendants
- K070405: Modification to Surgisis SLR Staple Line Reinforcement (2007), 2 descendants of its own
- 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
SURGISlS® Staple Line Reinforcement Il 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, pneumonectomylpneumectomy, 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 non-anastomnotic staplers. The device is supplied sterile and is intended for one-time use.

Source page: https://510kreport.com/device/K051048
Methodology: https://510kreport.com/methodology