# K022777: Manual Touche System

- Pathway: 510(k) (Traditional)
- Applicant: Onux Medical, Inc.
- Decided: Nov 19, 2002 after 90 days
- Product code: GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile)
- 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
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) Powered Touch6 Suturing System: named in the summary without a submission number
- (no number) Salute Fixation System: named in the summary without a submission number

## Indications for use
The Manual Touche Suturing System has applications in’gynecological, orthopaedic, and general abdominal; endoluminal, open and thoracic endoscopic surgical wound closure procedures (e.g. creation of anastomosis, hernia repair, ligation and hemostasis).

Source page: https://510kreport.com/device/K022777
Methodology: https://510kreport.com/methodology