# K120299: SRS Endoscopic Stapling System

- Pathway: 510(k) (Traditional)
- Applicant: Medigus, Ltd.
- Decided: May 18, 2012 after 108 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: 5 generations back to K972679 (1997). 12 ancestors in all.
3 later devices descend 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)
- K023234: Endoscopic Plication System, Ndo Surgical, Inc. (2003) Summary page 2.
- K031262: Endoscopic Plication System, Model 160-00760, Ndo Surgical, Inc. (2003) Summary page 2.
- K071553: Endoscopic Plication System; Eps; Plicator, Ndo Surgical, Inc. (2007) Summary page 2.
- K071651: Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and Accessories, Endogastric Solutions, Inc. (2007) Summary page 2.

## Most influential descendants
- K132151: SRS Endoscopic Stapling System (2014), 2 descendants of its own
- K143634: MUSE System (2015), 1 descendant of its own
- K151001: MUSE System (2015), 0 descendants of its own

## Indications for use
The SRS Endoscopic Stapling 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 phtarmacological therapy.

Source page: https://510kreport.com/device/K120299
Methodology: https://510kreport.com/methodology