MUSE System

Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd)

MEDIGUS LTD.

The following data is part of a premarket notification filed by Medigus Ltd. with the FDA for Muse System.

Pre-market Notification Details

Device IDK143634
510k NumberK143634
Device Name:MUSE System
ClassificationEndoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd)
Applicant MEDIGUS LTD. BUILDING 7A, OMER IMDUSTRIAL PARK Omer,  IL 84965
ContactSharon Kanety Deresh
CorrespondentSheila S Stevens
MEDIGUS LTD. 2121 NORTH CALIFORNIA BLVD, SUITE 290 Walnut Creek,  CA  94596
Product CodeODE  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-22
Decision Date2015-01-20
Summary:summary

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