Cleared Traditional

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

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence.

K190006 · Levita Magnetics International Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Levita Magnetics International Corp devices

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 130d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

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

Regulatory Consultant

Domecus Consulting Services, LLC
Cindy Domecus

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.

Clinical Evidence

ClinicalTrials.gov
NCT03624465 Completed Interventional Industry-sponsored

Prospective Clinical Study of the Levita Magnetics Surgical System Used for Prostatectomy Surgery

30
Patients (actual)
1
Site
Other
Purpose
Open label
Masking
Condition studied Prostatectomy
Study design Single group
Eligibility Male only · 18 Years+
Principal investigator Matthew Gettman, MD
Sponsor Levita Magnetics (industry)
Started 2018-08-13 → Primary completion 2019-03-25
Primary outcome
Number of Tools Required to Retract the Prostate During Procedure
View full study on ClinicalTrials.gov

Regulatory Peers - PNL Magnetic Surgical System

Devices cleared under the same product code (PNL) and FDA review panel - the closest regulatory comparables to K190006.
Magnetic Surgical System
K250746 · Levita Magnetics International Corp · Jun 2025
Surgeon Controlled Arm
K223673 · Levita Magnetics International Corp · Aug 2023
Magnetic Surgical System
K191762 · Levita Magnetics International Corp · Apr 2020
Magnetic Surgical System
K180894 · Levita Magnetics International Corp · Sep 2018