# K182832: Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jun 26, 2019 after 260 days
- Product code: KGC (Tube, Gastro-Enterostomy)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K873606 (1988). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K873606: Modified Cope Suture Anchor, Cook, Inc. (1988) Summary page 5.

## Most influential descendants
- K193612: AMT Suture Delivery System (2020), 1 descendant of its own
- K241111: AMT Suture Passer (2024), 0 descendants of its own

## Indications for use
The Cope Pediatric Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to the introduction of interventional catheters and can stay in place for up to 14 days in infant, child, and adolescent populations. The Enterostomy Suture Anchor Set is intended for anchoring the wall of a hollow viscus to the abdominal wall prior to the introduction of interventional catheters and stay in place for up to 14 days in child, adolescent, and adult populations.

Source page: https://510kreport.com/device/K182832
Methodology: https://510kreport.com/methodology