Magnetic Surgical System
The Magnetic Surgical System (product code PNL) is a Class 2 general and plastic surgery prescription device designed to grasp and retract the body and fundus of the gallbladder in laparoscopic cholecystectomy procedures to facilitate access and visualization of the surgical site, regulated under 878.4815. It is indicated for patients with a BMI range of 20 to 34 kg/m2 and requires 510(k) clearance. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PNL
- Device Class
- FDA class 2
- Regulation Number
- 878.4815
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252435 | Magnetic Surgical System | Sep 26, 2025 | Substantially Equivalent | Levita Magnetics International Corp |
| K250746 | Magnetic Surgical System | Jun 07, 2025 | Substantially Equivalent | Levita Magnetics International Corp |
| K223673 | Surgeon Controlled Arm | Aug 04, 2023 | Substantially Equivalent | Levita Magnetics International Corp |
| K191762 | Magnetic Surgical System | Apr 01, 2020 | Substantially Equivalent | Levita Magnetics International Corp |
| K190006 | Magnetic Surgical System | Apr 29, 2019 | Substantially Equivalent | Levita Magnetics International Corp |
| K180894 | Magnetic Surgical System | Sep 19, 2018 | Substantially Equivalent | Levita Magnetics International Corp |
| K171429 | Magnetic Surgical System | Jun 06, 2017 | Substantially Equivalent | Levita Magnetics International Corp |
| DEN150007 | Magnetic Surgical System | Jun 13, 2016 | Unknown | Levita Magnetics International Corp |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.