Cleared Special

K151001 - MUSE System

K151001 is an FDA 510(k) clearance for MUSE System, manufactured by Medigus , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code ODE cleared through the Special 510(k) pathway after a 51-day FDA review.

K151001 · Medigus , Ltd. · Gastroenterology & Urology device
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Jun 2015
Decision
51d
Days
Class 2
Risk

K151001 is an FDA 510(k) clearance for the MUSE System. Classified as Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) (product code ODE), Class II - Special Controls.

Submitted by Medigus , Ltd. (Omer, IL). The FDA issued a Cleared decision on June 5, 2015 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medigus , Ltd. devices

FDA 510(k) Submission Details - K151001

510(k) Number K151001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2015
Decision Date June 05, 2015
Days to Decision 51 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 131d · This submission: 51d
Pathway characteristics
Modification to existing cleared device.

ODE Device Classification - Class 2, Special Controls

Product Code ODE Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Treat The Symptoms Of Chronic Gastroesophageal Reflux Disease (gerd), Either By Approximating Tissue With Sutures Or Plicating Tissue With An Implant.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Sheila S. Stevens
SHEILA S. STEVENS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ODE Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd)

All 16
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