# K023372: Non-Bioabsorbable Staple

- Pathway: 510(k) (Traditional)
- Applicant: Onux Medical, Inc.
- Decided: Dec 27, 2002 after 80 days
- Product code: NJU (Suture, Nonabsorbable, Nitinol)
- Device class: 2
- Regulation: 21 CFR 878.4495
- 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 K944415 (1994). 4 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013749: Endoanchor and Openanchor, Ethicon Endo-Surgery, Inc. (2002)

## Most influential descendants
- K061276: G-Prox Endoscopic Grasper (2006), 5 descendants of its own
- K100251: G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333 (2010), 1 descendant of its own
- K093018: G-Prox Endoscopic Grasper, Model 205333 (2009), 1 descendant of its own
- K103688: G-Prox EZ Endoscopic Grasper (2011), 0 descendants of its own
- K102931: G-Cinch Suture Grasper (2010), 0 descendants of its own

## Indications for use
The Coil Fixation Device is intended for fixation of prosthetic material and approximation of tissue in endoscopic and open surgical procedures.

Source page: https://510kreport.com/device/K023372
Methodology: https://510kreport.com/methodology
