# K153202: iMESH Tacker

- Pathway: 510(k) (Special)
- Applicant: Thd Lap
- Decided: Mar 24, 2016 after 141 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K951658 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110728: Imesh Tacker, Easylap, Ltd. (2011) Summary page 5.

## Indications for use
The iMESH Tacker is indicated for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.

Source page: https://510kreport.com/device/K153202
Methodology: https://510kreport.com/methodology