# K801590: Auto Suture Disposable Gia Surg. Stapler

- 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.
24 later devices descend from it; 2 cite it directly.
0 of 25 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
- K090821: Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L (2009), 21 descendants of its own
- K120179: Reach Surgical Staplers (2012), 17 descendants of its own
- K131511: Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear Staplers and Reloads, Disposable Hemorr (2013), 14 descendants of its own
- K141367: LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and Reloads, LC Series Linear Cutter and Reloads (2014), 7 descendants of its own
- K173443: AEON Endoscopic Stapler (2018), 5 descendants of its own

Source page: https://510kreport.com/device/K801590
Methodology: https://510kreport.com/methodology