Cleared Traditional

K120299 - SRS ENDOSCOPIC STAPLING SYSTEM

K120299 is an FDA 510(k) clearance for SRS ENDOSCOPIC STAPLING SYSTEM, manufactured by Medigus , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code ODE cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K120299 · Medigus , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
108d
Days
Class 2
Risk

K120299 is an FDA 510(k) clearance for the SRS ENDOSCOPIC STAPLING SYSTEM. Classified as Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) (product code ODE), Class II - Special Controls.

Submitted by Medigus , Ltd. (Washington D.C., US). The FDA issued a Cleared decision on May 18, 2012 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medigus , Ltd. devices

FDA 510(k) Submission Details - K120299

510(k) Number K120299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2012
Decision Date May 18, 2012
Days to Decision 108 days
Submission Type Traditional
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
23d faster than avg
Panel avg: 131d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00734747 Completed Interventional Industry-sponsored

Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)

Evaluation of the Medigus SRS Endoscopic Stapling System for the Treatment of Gastro-Esophageal Reflux Disease (GERD)

72
Patients (actual)
6
Sites
Treatment
Purpose
Open label
Masking
Condition studied Gastroesophageal Reflux Disease (GERD)
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Aviel Roy-Shapira, M.D.
Sponsor Aviel Roy-Shapira, M.D. (industry)
Started 2008-05-01 → Primary completion 2011-05-01 → Completed 2015-07-01
Primary outcome
Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score
Secondary outcome
Reduction of Acid Exposure (%Time pH<4) on Off PPI Ambulatory 24h Acid Exposure Test
View full study on ClinicalTrials.gov

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

All 16
Devices cleared under the same product code (ODE) and FDA review panel - the closest regulatory comparables to K120299.
MUSE System
K143634 · Medigus , Ltd. · Jan 2015
ESOPHYX2 HD
K142113 · Endogastric Solutions, Inc. · Sep 2014
SRS ENDOSCOPIC STAPLING SYSTEM
K132151 · Medigus , Ltd. · Mar 2014
ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5
K092400 · Endogastric Solutions, Inc. · Nov 2009
ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT
K072125 · Ndo Surgical, Inc. · Oct 2007
ENDOSCOPIC PLICATION SYSTEM
K071553 · Ndo Surgical, Inc. · Sep 2007