# K253541: EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)

- Pathway: 510(k) (Traditional)
- Applicant: Medical Impact
- Decided: Jul 24, 2026 after 252 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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: 2 generations back to K103412 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132362: Weck Efx Endo Fascial Closure System, Teleflexmedical, Inc. (2013) Summary page 5.

## Indications for use
The EZ-Close™ is indicated to close perforated peritoneum and fascia for trocar insertion during laparoscopic surgery.

Source page: https://510kreport.com/device/K253541
Methodology: https://510kreport.com/methodology