# K142639: StitchKit

- Pathway: 510(k) (Traditional)
- Applicant: Origami Surgical, LLC
- Decided: Dec 16, 2014 after 90 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- 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.
- K133356: Prolene Polypropylene Nonabsorbable Suture, ETHICON, Inc. (2013) Summary page 4.

## Indications for use
StitchKit® Suture Delivery Canister with Polypropylene Surgical Suture facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. It contains polypropylene surgical suture indicated for use in general soft tissue approximation and/or ligation.

Source page: https://510kreport.com/device/K142639
Methodology: https://510kreport.com/methodology