Not Cleared Direct

DEN150007 - Magnetic Surgical System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN150007 · Levita Magnetics International Corp · General & Plastic Surgery device
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Jun 2016
Decision
489d
Days
Class 2
Risk

DEN150007 is an FDA 510(k) submission (not cleared) 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 Not Cleared (DENG) decision on June 13, 2016 after a review of 489 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4815 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 489 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Levita Magnetics International Corp devices

Submission Details

510(k) Number DEN150007 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 10, 2015
Decision Date June 13, 2016
Days to Decision 489 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
375d slower than avg
Panel avg: 114d · This submission: 489d
Pathway characteristics

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 General & Plastic Surgery devices follow this clearance model.