# DEN140020: Eclipse System

- Pathway: De Novo (Direct)
- Applicant: Pelvalon
- Decided: Feb 12, 2015 after 233 days
- Product code: PJH (Dynamic Rectal Control System)
- Device class: 2
- Regulation: 21 CFR 876.5930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K150558: Eclipse System (2015), 0 descendants of its own

## Indications for use
The Eclipse System, a prescription device under 21 CFR Part 801.109 that is indicated for the treatment of fecal incontinence in adult women.

Source page: https://510kreport.com/device/DEN140020
Methodology: https://510kreport.com/methodology