# K123811: Stitchkit

- Pathway: 510(k) (Traditional)
- Applicant: Origami Surgical, LLC
- Decided: Sep 5, 2013 after 268 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: 2 generations back to K954853 (1995). 2 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981531: Suture Placement Device and Accessories, Lsi Solutions (1998) Summary page 2.
- (no number) Gore-Tex Nonabsorbable ePTFE Surgical Suture: named in the summary without a submission number

## Most influential descendants
- K173874: StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO (2018), 3 descendants of its own
- K202950: StitchKit COMBO (2021), 2 descendants of its own
- K211792: StitchKit (2021), 1 descendant of its own
- K221527: StitchKit (2023), 0 descendants of its own
- K191317: StitchKit (2019), 0 descendants of its own

## Indications for use
The StitchKit device facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. The ePTFE suture contained within StltchKito is indicated for use in all types of soft tissue approximation, including use in cardiovascular surgery and dura mater repair. It is recommended for use where reduced suture line bleeding during cardiovascular anastamotic procedures is desired.

Source page: https://510kreport.com/device/K123811
Methodology: https://510kreport.com/methodology