# K191070: Signia Small Diameter Reloads

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Sep 4, 2019 after 135 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K842066 (1985). 65 ancestors in all.
2 later devices descend 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)
- K111825: Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM) Staplers, Covidien, Formerly US Surgical A Divison of Tyco H (2011) Summary page 4.
- K141952: Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon Vascular White Reloads for Advanced, Ethicon Endo-Surgery, Inc. (2014) Summary page 4.

## Most influential descendants
- K222641: Signia™ Small Diameter Reloads Including Regular (Round) Tip Version (2022), 1 descendant of its own
- 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-0486-2026: 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.
- 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.
- Feb 14, 2024 · Class II · Z-1457-2024: Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads th
- Feb 14, 2024 · Class II · Z-1458-2024: Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads th
- Mar 4, 2021 · Class II · Z-1383-2021: Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty sing
- Mar 4, 2021 · Class II · Z-1384-2021: Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty sing
- Mar 4, 2021 · Class II · Z-1385-2021: Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty sing

## Indications for use
The Signia™ small diameter gray and white reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of vasculature using gray reloads and thin tissue and vasculature using white reloads.

Source page: https://510kreport.com/device/K191070
Methodology: https://510kreport.com/methodology