# K001785: Surgisis Peripheral Vascular Patch

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: Dec 27, 2000 after 197 days
- Product code: DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022044: Surgisis Staple Line Reinforcement (2002), 6 descendants of its own
- 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

## Recalls of this device
- Dec 13, 2002 · Not classified · Z-0577-03: Adverse events- suspected pseudoaneurysm

Source page: https://510kreport.com/device/K001785
Methodology: https://510kreport.com/methodology