# K963999: Auto Suture* Modified Endoscopic Fascia Stapler** Device

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Nov 27, 1996 after 51 days
- Product code: OCW (Endoscopic Tissue Approximation Device)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944415 (1994). 1 ancestor in all.
23 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944415: Origin Tacker System, Origin Medsystems, Inc. (1994) Summary page 1.

## Most influential descendants
- K090470: Autosuture Protack; Tacker System; Absorbatack Fixation Devices (2009), 12 descendants of its own
- K013749: Endoanchor and Openanchor (2002), 7 descendants of its own
- K023372: Non-Bioabsorbable Staple (2002), 6 descendants of its own
- K061276: G-Prox Endoscopic Grasper (2006), 5 descendants of its own
- K123109: Absorbatack 5MM Single Use Absorbable Fixation Device (2012), 4 descendants of its own

## Recalls of this device
- Feb 8, 2010 · Not classified · Z-1157-2010: Fixation device may fail to fire and staple.

## Indications for use
The AUTO SUTURE* Modified Endoscopic Fascia Stapler** device is intended for use in affixing prosthetic material or approximating tissue. This device may be used both endoscopically and in open procedures.

Source page: https://510kreport.com/device/K963999
Methodology: https://510kreport.com/methodology