# K193612: AMT Suture Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Technology, Inc.
- Decided: Mar 12, 2020 after 77 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: 2 generations back to K873606 (1988). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K182832: Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set, Cook Incorporated (2019) Summary page 4.

## Most influential descendants
- K241111: AMT Suture Passer (2024), 0 descendants of its own

## Indications for use
The AMT Suture Delivery System 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/K193612
Methodology: https://510kreport.com/methodology