# K201808: X-Tack Endoscopic HeliX Tacking System

- Pathway: 510(k) (Traditional)
- Applicant: Apollo Endosurgery, Inc.
- Decided: Dec 15, 2020 after 167 days
- Product code: PKL (Hemostatic Metal Clip For The Gi Tract)
- Device class: 2
- Regulation: 21 CFR 876.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K963160 (1997). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151802: Resolution Clip, Boston Scientific Corporation (2015) Summary page 4.

## Most influential descendants
- K251229: EndoFix™Tissue Fixation System (2025), 0 descendants of its own

## Recalls of this device
- Jul 14, 2026 · Class II · Z-2961-2026: Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
- Jul 14, 2026 · Class II · Z-2962-2026: Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.

## Indications for use
The X-Tack™ Endoscopic HeliX Tacking System is intended for approximation of soft tissue in minimally invasive gastroenterology procedures (e.g. closure and healing of ESD/EMR sites, and closing of fistula, perforation or leaks). X-Tack is not intended for hemostasis of acute bleeding ulcers.

Source page: https://510kreport.com/device/K201808
Methodology: https://510kreport.com/methodology