Cleared Traditional

K190006 - Magnetic Surgical System (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190006 · Levita Magnetics International Corp · Gastroenterology & Urology device
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Apr 2019
Decision
117d
Days
Class 2
Risk

K190006 is an FDA 510(k) clearance for the Magnetic Surgical System. Classified as Magnetic Surgical System (product code PNL), Class II - Special Controls.

Submitted by Levita Magnetics International Corp (San Mateo, US). The FDA issued a Cleared decision on April 29, 2019 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.4815 - 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.

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Submission Details

510(k) Number K190006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2019
Decision Date April 29, 2019
Days to Decision 117 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
13d faster than avg
Panel avg: 130d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PNL Magnetic Surgical System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4815
Definition System Designed To Grasp And Retract The Body And The Fundus Of The Gallbladder In Laparoscopic Cholecystectomy Procedures To Facilitate Access And Visualization Of The Surgical Site. The Device Is Indicated For Use In Patients Within A Bmi Range Of 20 To 34 Kg/m2. The Device Is Intended For Prescription Use Only.
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.