# K211792: StitchKit

- Pathway: 510(k) (Special)
- Applicant: Origami Surgical Inc .
- Decided: Jul 16, 2021 after 36 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: 10 generations back to K014153 (2002). 43 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202950: StitchKit COMBO, Origami Surgical (2021) Summary page 4.
- K000037: Monofilament Biosyn Suture, United States Surgical, A Division of Tyco Healthc (2000) Summary page 4.
- K990951: Maxon** Sterile, Synthetic, Absorbable Suture, United States Surgical, A Division of Tyco Healthc (1999) Summary page 4.
- K103052: V-Loc (TM) Nonabsorbable Wound Closure Device, Covidien, LLC (2010) Summary page 4.
- K930591: TI-Cron and Dacron Sutures, Davis & Geck, Inc. (1993) Summary page 4.

## Most influential descendants
- 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 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/K211792
Methodology: https://510kreport.com/methodology