# K172666: CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor

- Pathway: 510(k) (Traditional)
- Applicant: Sutureease, Inc.
- Decided: Dec 1, 2017 after 87 days
- Product code: OCW (Endoscopic Tissue Approximation Device)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K103412 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132362: Weck Efx Endo Fascial Closure System, Teleflexmedical, Inc. (2013) Summary page 4.

## Indications for use
This product is intended to pass suture through soft tissue layers (fascia, muscle and peritoneum) of a trocar wound at the end of laparoscopic surgery. It is to be used only by surgeons trained in endoscopic/laparoscopic surgery.

Source page: https://510kreport.com/device/K172666
Methodology: https://510kreport.com/methodology