# K150558: Eclipse System

- Pathway: 510(k) (Traditional)
- Applicant: Pelvalon, Inc.
- Decided: Nov 12, 2015 after 253 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
Longest line of descent: 1 generation back to DEN140020 (2015). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN140020: Eclipse System, Pelvalon (2015) Summary page 4.

## Indications for use
The Eclipse System is indicated for the treatment of fecal incontinence in adult women.

Source page: https://510kreport.com/device/K150558
Methodology: https://510kreport.com/methodology