# K151001: MUSE System

- Pathway: 510(k) (Special)
- Applicant: Medigus, Ltd.
- Decided: Jun 5, 2015 after 51 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: 8 generations back to K972679 (1997). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143634: MUSE System, Medigus, Ltd. (2015) Summary page 4.

## Indications for use
The Medigus Ultrasonic Surgical Endostapler (MUSETM) 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/K151001
Methodology: https://510kreport.com/methodology