Magnetic Surgical System
General, Plastic Surgery · 21 CFR 878.4815
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.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
7 firms currently registered for this product code
510(k) clearances
8 clearances for this product code
- Levita Magnetics International CorpSep 26, 2025
K252435 · Magnetic Surgical System
- Levita Magnetics International CorpJun 7, 2025
K250746 · Magnetic Surgical System
- Levita Magnetics International CorpAug 4, 2023
K223673 · Surgeon Controlled Arm
- Levita Magnetics International CorpApr 1, 2020
K191762 · Magnetic Surgical System
- Levita Magnetics International CorpApr 29, 2019
K190006 · Magnetic Surgical System
- Levita Magnetics International CorpSep 19, 2018
K180894 · Magnetic Surgical System
- Levita Magnetics International CorpJun 6, 2017
K171429 · Magnetic Surgical System
- Levita Magnetics International CorpJun 13, 2016
DEN150007 · Magnetic Surgical System