# K983318: Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: General Surgical Innovations
- Decided: Mar 1, 1999 after 161 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Origin Tacker™ System: named in the summary without a submission number
- (no number) AUTO SUTURE™ Modified Endoscopic Fascia Stapler: named in the summary without a submission number
- (no number) Endoscopic Multifeed Stapler: named in the summary without a submission number

## Indications for use
The indications statement for the New Device and the Predicate Devices is the same. All of the devices are used for approximating tissue and affixing prosthetic material. Both endoscopic and open procedures.

Source page: https://510kreport.com/device/K983318
Methodology: https://510kreport.com/methodology