# K022044: Surgisis Staple Line Reinforcement

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: Aug 23, 2002 after 60 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: 3 generations back to K921895 (1992). 11 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 1.
- K001785: Surgisis Peripheral Vascular Patch, Cook Biotech, Inc. (2000) Summary page 1.
- K983162: Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc, Bio-Vascular, Inc. (1998) Summary page 1.
- K010936: Modification to Seamguard Staple Line Reinforcement Material, W. L. Gore & Associates, Inc. (2001) Summary page 1.

## Most influential descendants
- K051048: Surgisis Staple Line Reinforcement II (2005), 3 descendants of its own
- 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
- K133011: Diaphragmatic Hernia Graft (2014), 1 descendant of its own
- K201000: Biodesign Staple Line Reinforcement (2020), 0 descendants of its own

## Indications for use
The Surgisis 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. The device can also be used for abdominal and thoracic wall repair, muscle flap reinforcement, trans-abdominal rectal and vaginal prolapse repair, trans-abdominal reconstruction of the pelvic floor, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical). The Surgisis® Staple Line Reinforcement 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/K022044
Methodology: https://510kreport.com/methodology