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
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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
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 130d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Devices cleared under the same product code (ODE) and FDA review panel - the closest regulatory comparables to K120299.
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