# Magnetic Surgical System
> **Product code: PNL** · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4815
## Classification
- **FDA Product Code:** PNL
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 878.4815
- **Review panel:** SU
- **Medical specialty:** General, Plastic Surgery
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 8
- **Registered establishments:** 4
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PNL)
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