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510(k) K190006

Device
Magnetic Surgical System
Applicant
Levita Magnetics International Corp.
510(k) number
K190006
Product code
PNL  
Decision
Substantially Equivalent (SESE)
Decision date
2019-04-29
Date received
2019-01-02
Regulation
878.4815
Classification name
Magnetic Surgical System
Medical specialty
General & Plastic Surgery
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Alberto Rodrigues-Navarro
Address
1730 S.Amphlett Blvd., Suite 240 San Mateo CA US 94402 94402

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PNL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252435Magnetic Surgical SystemLevita Magnetics International Corp2025-09-26
K250746Magnetic Surgical SystemLevita Magnetics International Corp2025-06-07
K223673Surgeon Controlled ArmLevita Magnetics International Corp2023-08-04
K191762Magnetic Surgical SystemLevita Magnetics International Corp2020-04-01
K180894Magnetic Surgical SystemLevita Magnetics International Corp2018-09-19
K171429Magnetic Surgical SystemLevita Magnetics International Corp2017-06-06
DEN150007Magnetic Surgical SystemLevita Magnetics International Corp2016-06-13

Legacy Summary#

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FDA Review#

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