# K221527: StitchKit

- Pathway: 510(k) (Traditional)
- Applicant: Origami Surgical Inc .
- Decided: Feb 14, 2023 after 264 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K014153 (2002). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211792: StitchKit, Origami Surgical Inc . (2021) Summary page 4.

## Indications for use
StitchKit® Suture Delivery Canister facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. The suture contained within the device is intended for soft tissue approximation where use of the specific absorbable or non-absorbable sutures contained within it is appropriate

Source page: https://510kreport.com/device/K221527
Methodology: https://510kreport.com/methodology