EsophyX Z Device with SerosaFuse Fasteners and Accessories
by Endogastric Solutions, Inc. United States(FDA 510(k) applicant) 510(k)
510(k) K160960 Product code ODE
Overview
The EsophyX Z Device with SerosaFuse Fasteners and Accessories is an Endoscopic Suture/Plication System designed for transoral tissue approximation, full-thickness plication, and ligation within the gastrointestinal tract. It employs implantable fasteners to distribute force circumferentially around the gastroesophageal junction, aiding in the treatment of symptomatic chronic GERD in patients who respond to pharmacological therapy. The system is deployed under direct endoscopic visualization via a flexible gastroscope, ensuring precise placement.
This device is supplied with reusable endoscopic components and single-use SerosaFuse Fasteners and accessories. It is intended for use in clinical settings such as gastroenterology and urology, adhering to standard endoscopic procedures. The device is not sterile at shipment and requires sterilization prior to use. It holds an FDA 510K clearance and is classified as a Class II medical device under product code ODE, regulated for the treatment of GERD.
EsophyX Z Device with SerosaFuse Fasteners and Accessories
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK160960 | Date1 May 2016 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- ODE
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Endogastric Solutions, Inc.
Questions
What is the EsophyX Z Device used for?
The EsophyX Z Device with SerosaFuse Fasteners is designed for endoscopic transoral tissue approximation and full-thickness plication at the gastroesophageal junction. It distributes force circumferentially using implantable fasteners to help treat symptomatic chronic GERD in patients who respond to medication. The system is deployed via a flexible gastroscope for precise placement under direct endoscopic visualization.
How is the EsophyX Z Device supplied, and is it sterile?
The device is supplied with reusable endoscopic components and single-use SerosaFuse Fasteners and accessories. It is not sterile at shipment and must be sterilized prior to use in clinical settings like gastroenterology or urology. Sterilization is a mandatory step before deployment to ensure patient safety.
Is the EsophyX Z Device single-use or reusable?
The SerosaFuse Fasteners and accessories are single-use components, while the reusable endoscopic components (e.g., delivery tools) are designed for multiple procedures. This distinction ensures sterility compliance and reduces waste from disposable elements while maintaining functionality for repeated use of the core system.
What regulatory pathway does the EsophyX Z Device follow?
The EsophyX Z Device holds FDA 510K clearance (K160960) and is classified as a Class II medical device under product code ODE. It was reviewed by the Gastroenterology and Urology (GU) Advisory Committee under a Special 510(k) pathway, with a decision date of May 1, 2016. This classification reflects its intended use for endoscopic plication in GERD treatment.
In which clinical specialties is the EsophyX Z Device primarily used?
The device is primarily utilized in gastroenterology and urology settings, adhering to standard endoscopic procedures. Its design aligns with clinical workflows where minimally invasive techniques for GERD management are employed, particularly for patients who do not achieve adequate symptom control with medication alone.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K160960