# K193652: AbClose - Port Site Closure Device

- Pathway: 510(k) (Traditional)
- Applicant: Medeon Biodesign, Inc.
- Decided: Mar 26, 2020 after 87 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: 3 generations back to K103412 (2010). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160117: AbClose - Port Site Closure Device, Medeon Biodesign, Inc. (2016) Summary page 4.

## Indications for use
The AbClose - Port Site Closure Device has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

Source page: https://510kreport.com/device/K193652
Methodology: https://510kreport.com/methodology