# K103412: Axiom Fascial Closure System

- Pathway: 510(k) (Traditional)
- Applicant: Axiom Technology Partners, LLC
- Decided: Dec 30, 2010 after 38 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
No predicates in its family tree.
6 later devices descend from it; 1 cites 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)
- None. The FDA summary names its predicate without a number.
- (no number) Covidien EndoClose: named in the summary without a submission number
- (no number) Cooper Surgical Carter-Thomason CloseSure System: named in the summary without a submission number

## Most influential descendants
- K132362: Weck Efx Endo Fascial Closure System (2013), 5 descendants of its own
- 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

## Indications for use
The Axiom Fascial Closure Device has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

Source page: https://510kreport.com/device/K103412
Methodology: https://510kreport.com/methodology