# K183398: Endoform Restella

- Pathway: 510(k) (Traditional)
- Applicant: Aroa Biosurgery, Ltd.
- Decided: Apr 11, 2019 after 125 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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 no predicate by number.

## Most influential descendants
- K214070: OviTex PRS (Long Term Resorbable) (2023), 1 descendant of its own
- K243595: OviTex PRS (Long-Term Resorbable) (2024), 0 descendants of its own
- K241126: OviTex PRS (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K183398
Methodology: https://510kreport.com/methodology