MUSE System

FDA 510(k) K143634 · Medigus , Ltd.

Substantially Equivalent

510(k) numberK143634

Submission

Device name
MUSE System
Applicant
Medigus , Ltd.
Omer, IL
Received
December 22, 2014
Decision date
January 20, 2015
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ODE – Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology
Implant
Yes

To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant.

Other 510(k)s with product code ODE

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K233240GERDX-SystemODE · Traditional G-Surg GmbH06/21/2024SE
K240879EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesODE · Special Endogastric Solutions, Inc.04/26/2024SE
K172811EsophyX Z, EsophyX2 HDODE · Traditional Endogastric Solutions, Inc.10/19/2017SE
K171307EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with…ODE · Traditional Endogastric Solutions, Inc.06/22/2017SE
K160960EsophyX® Z Device with SerosaFuse Fasteners and AccessoriesODE · Special Endogastric Solutions, Inc.05/01/2016SE
K151001MUSE SystemODE · Special Medigus , Ltd.06/05/2015SE
K143645EsophyX® Z Fastener Delivery DeviceODE · Traditional Endogastric Solutions, Inc.03/04/2015SE
K142113ESOPHYX2 HDODE · Special Endogastric Solutions, Inc.09/30/2014SE
K132151SRS Endoscopic Stapling SystemODE · Traditional Medigus , Ltd.03/19/2014SE
K120299SRS Endoscopic Stapling SystemODE · Traditional Medigus , Ltd.05/18/2012SE

More from Medigus , Ltd.

510(k)DeviceDecision
K151001MUSE SystemODE · Special 06/05/2015SE
K132151SRS Endoscopic Stapling SystemODE · Traditional 03/19/2014SE
K120299SRS Endoscopic Stapling SystemODE · Traditional 05/18/2012SE

Questions and answers

When was MUSE System cleared by the FDA?

MUSE System (K143634) received a 510(k) decision of Substantially Equivalent on January 20, 2015, 29 days after the submission was received.

What is the product code of K143634?

The FDA product code is ODE – Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd), a Class II (moderate risk) device regulated under 21 CFR 876.1500.