# K132362: Weck Efx Endo Fascial Closure System

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Oct 8, 2013 after 70 days
- Product code: OCW (Endoscopic Tissue Approximation Device)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K103412 (2010). 1 ancestor in all.
5 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103412: Axiom Fascial Closure System, Axiom Technology Partners, LLC (2010) Summary page 2.

## Most influential descendants
- K160117: AbClose - Port Site Closure Device (2016), 1 descendant of its own
- K253541: EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device) (2026), 0 descendants of its own
- K213271: MedicloseTM System (2023), 0 descendants of its own
- K193652: AbClose - Port Site Closure Device (2020), 0 descendants of its own
- K172666: CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor (2017), 0 descendants of its own

## Indications for use
The WECK®D EFxTh Endo Fascial Closure System has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

Source page: https://510kreport.com/device/K132362
Methodology: https://510kreport.com/methodology