# K191317: StitchKit

- Pathway: 510(k) (Traditional)
- Applicant: Origami Surgical
- Decided: Jul 12, 2019 after 58 days
- Product code: NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene)
- Device class: 2
- Regulation: 21 CFR 878.5035
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K954853 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123811: Stitchkit, Origami Surgical, LLC (2013) Summary page 4.
- K140415: Monotex, Riverpoint Medical (2014) Summary page 4.

## Indications for use
The StitchKit® device facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. Monotex® PTFE surgical suture is indicated for use in general soft tissue approximation and/or ligation, including cardiovascular, dental, general surgical procedures and repair of the dura mater. Monotex® PTFE sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. Monotex® PTFE suture is provided sterile as a single use device.

Source page: https://510kreport.com/device/K191317
Methodology: https://510kreport.com/methodology