# K202950: StitchKit COMBO

- Pathway: 510(k) (Traditional)
- Applicant: Origami Surgical
- Decided: Feb 23, 2021 after 146 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: 9 generations back to K014153 (2002). 39 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173874: StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO, Origami Surgical, LLC (2018) Summary page 4.
- K981935: Polysorb Suture, United States Surgical, A Division of Tyco Healthc (1998) Summary page 4.
- K980124: Sofsilk Suture, United States Surgical, A Division of Tyco Healthc (1998) Summary page 4.

## Most influential descendants
- K211792: StitchKit (2021), 1 descendant of its own
- K221527: StitchKit (2023), 0 descendants of its own

## 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 StitchKit® 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/K202950
Methodology: https://510kreport.com/methodology