# K071796: Capsew Plication System

- Pathway: 510(k) (Traditional)
- Applicant: Cayenne Medical, Inc.
- Decided: Oct 19, 2007 after 109 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K990088 (1999). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042031: Opus Speedstitch Suture Device, Opus Medical, Inc. (2004) Summary page 2.
- K041894: Orthofiber, Cp Medical (2004) Summary page 2.
- K063778: Force Fiber Polyethylene Nonabsorbable Suture, Teleflex Medical (2007) Summary page 2.
- K001434: 'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture, Genzyme Surgical Product (Genzyme Biosurgery) (2000) Summary page 2.

## Indications for use
The CapSew Plication System is intended for use in placement of suture through soft tissue in arthroscopic and open surgical procedures.

Source page: https://510kreport.com/device/K071796
Methodology: https://510kreport.com/methodology