# K014286: Salute, Model 3022

- Pathway: 510(k) (Traditional)
- Applicant: Onux Medical, Inc.
- Decided: Mar 8, 2002 after 71 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) ProTack™ laparoscopic stapler: named in the summary without a submission number
- (no number) Ethicon staples (e.g. Proximate™ staples): named in the summary without a submission number

## Indications for use
The Salute Fixation System is indicated for use in a variety of laparoscopic / endoscopic or open surgical procedures for fixation of prosthetic material and approximation of tissue.

Source page: https://510kreport.com/device/K014286
Methodology: https://510kreport.com/methodology