# K801589: Auto Suture Disp. 30, Etc. & Surg. Stap

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Aug 4, 1980 after 24 days
- Product code: FHM (Apparatus, Suturing, Stomach And Intestinal)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K102325: Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload) (2010), 9 descendants of its own
- K121510: Idrive Ultra Powered Handle Endo Gia Adapter (2012), 8 descendants of its own
- K160176: Signia Stapler (2016), 5 descendants of its own
- K202864: Tri-Staple 2.0 Reloads (2020), 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

Source page: https://510kreport.com/device/K801589
Methodology: https://510kreport.com/methodology