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
| Device Type ID | 5872 |
| Device Name | Magnetic Surgical System |
| Physical State | The Device Is Two Different Instruments, The Magnetic Controller Which Is Outside Of The Body And Is 3x2 Inches, Oval-shaped With Handles And Is A Large Magnet Made Of NdFeB, Grade N42 Disk Magnet. The Second Instrument Is The Detachable Grasper Whic |
| Technical Method | Uses A Detachable Grasper That Can Be Attracted With A Magnet That Goes Into The Body To Grasp And Retract The Gallbladder. Externally, A Large Magnet Is Kept Outside Of The Body To Hold The Detachable Grasper In Place During Surgery With Its Magneti |
| Target Area | The Magnetic Controller Is Kept External To The Body On The Abdomen. The Detachable Grasper Is Used During Laparoscopic Cholecystectomy To Grasp And Retract The Gallbladder Inside The Body. |
| Regulation Description | Magnetic Surgical Instrument System. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4815 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PNL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5872 |
| Device | Magnetic Surgical System |
| Product Code | PNL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Magnetic Surgical Instrument System. |
| CFR Regulation Number | 878.4815 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
LEVITA MAGNETICS INTERNATIONAL CORP. | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 2 | |