# K994290: Bard Endoscopic Suturing System

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Mar 20, 2000 after 90 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: 2 generations back to K972679 (1997). 3 ancestors in all.
23 later devices descend from it; 4 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934738: Autosuture Endoscopic Suturing Device, United States Surgical, A Division of Tyco Healthc (1994) Summary page 4.
- K980022: Endopath Endoscopic Tissue Fastening System (Etfs), Ethicon Endo-Surgery, Inc. (1998) Summary page 4.

## Most influential descendants
- K062875: Endogastric Stomaphyx Device and Accessories (2007), 21 descendants of its own
- K071651: Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and Accessories (2007), 15 descendants of its own
- K092400: Endogastric Solutions ESOPHYX2 System with Serosafuse Fastener and Accessories, Model 2.7.5 (2009), 6 descendants of its own
- K142113: ESOPHYX2 HD (2014), 5 descendants of its own
- K143645: EsophyX® Z Fastener Delivery Device (2015), 4 descendants of its own

## Indications for use
For endoscopic placement of suture(s) in the soft tissue of the esophagus and stomach and for approximation of tissue for the treatment of symptomatic Gastroesophageal Reflux Disease.

Source page: https://510kreport.com/device/K994290
Methodology: https://510kreport.com/methodology