# K143634: MUSE System

- Pathway: 510(k) (Special)
- Applicant: Medigus, Ltd.
- Decided: Jan 20, 2015 after 29 days
- Product code: ODE (Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd))
- 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: 7 generations back to K972679 (1997). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132151: SRS Endoscopic Stapling System, Medigus, Ltd. (2014) Summary page 4.

## Most influential descendants
- K151001: MUSE System (2015), 0 descendants of its own

## Indications for use
The MUSE System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach in order to create anterior partial fundoplication for treatment of symptomatic chronic Gastro Esophageal Reflux Disease in patients who require and respond to pharmacological therapy

Source page: https://510kreport.com/device/K143634
Methodology: https://510kreport.com/methodology