# K222641: Signia™ Small Diameter Reloads Including Regular (Round) Tip Version

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Nov 29, 2022 after 89 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K842066 (1985). 66 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191070: Signia Small Diameter Reloads, Covidien (2019) Summary page 4.

## Most influential descendants
- K253657: Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads (2026), 0 descendants of its own

## Recalls of this device
- Sep 25, 2025 · Class II · Z-0485-2026: A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.

## Indications for use
The SigniaTM small diameter cuived tip gray and white re loads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and transection ofvasculature using gray reloads and thin tissue and vasculature using white reloads. The SigniaTM small diameter regular (round) tip white reload has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of thin tissue and vasculature and the creation of anastomosis.

Source page: https://510kreport.com/device/K222641
Methodology: https://510kreport.com/methodology