# K013749: Endoanchor and Openanchor

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Feb 11, 2002 after 90 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- 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 K944415 (1994). 3 ancestors in all.
7 later devices descend from it; 2 cite 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)
- K913469: Endopath Disposable Endoscopic Multifeed Stapler, ETHICON, Inc. (1991) Summary page 1.
- K963999: Auto Suture* Modified Endoscopic Fascia Stapler** Device, United States Surgical, A Division of Tyco Healthc (1996) Summary page 1.

## Most influential descendants
- K023372: Non-Bioabsorbable Staple (2002), 6 descendants of its own
- 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

## Indications for use
The EndoANCHOR Fixation Device is intended for fixation of prosthetic material to and approximation of soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair. The OpenANCHOR Fixation Device is intended for fixation of prosthetic material to and approximation of soft tissue in various open general surgical procedures, such as hernia repair.

Source page: https://510kreport.com/device/K013749
Methodology: https://510kreport.com/methodology