510(k) K250746

Magnetic Surgical System by Levita Magnetics International Corp — Product Code PNL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 7, 2025
Date Received: March 12, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Magnetic Surgical System
Device Class: Class II
Regulation Number: 878.4815
Review Panel: SU
Submission Type

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.

Other clearances by Levita Magnetics International Corp

K252435 — Magnetic Surgical System (September 26, 2025)
K223673 — Surgeon Controlled Arm (August 4, 2023)
K191762 — Magnetic Surgical System (April 1, 2020)
K190006 — Magnetic Surgical System (April 29, 2019)
K180894 — Magnetic Surgical System (September 19, 2018)
K171429 — Magnetic Surgical System (June 6, 2017)
DEN150007 — Magnetic Surgical System (June 13, 2016)

Other clearances for product code PNL

K252435 — Magnetic Surgical System (September 26, 2025)
K223673 — Surgeon Controlled Arm (August 4, 2023)
K191762 — Magnetic Surgical System (April 1, 2020)
K190006 — Magnetic Surgical System (April 29, 2019)
K180894 — Magnetic Surgical System (September 19, 2018)
K171429 — Magnetic Surgical System (June 6, 2017)
DEN150007 — Magnetic Surgical System (June 13, 2016)