# K082518: Dual Needle Suture Passer System

- Pathway: 510(k) (Traditional)
- Applicant: Cayenne Medical, Inc.
- Decided: Jan 16, 2009 after 136 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). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063778: Force Fiber Polyethylene Nonabsorbable Suture, Teleflex Medical (2007) Summary page 2.
- K041894: Orthofiber, Cp Medical (2004) Summary page 2.
- K023388: Mitek Rapidloc-PDS Meniscal Repair System, Mitek Worldwide (2002) Summary page 2.
- K062307: Xclose Tissue Repair System, Model SRS, Anulex Technologies, Inc. (2006) Summary page 2.
- K072322: Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems, Smith & Nephew, Inc. (2007) Summary page 2.

## Indications for use
The Dual Needle Suture Passei System is intended for approximation of soft tissue m procedures such as memscal repair

Source page: https://510kreport.com/device/K082518
Methodology: https://510kreport.com/methodology