FDA Product Code PNL: Magnetic Surgical System
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.
Leading manufacturers include Levita Magnetics International Corp.
FDA 510(k) Cleared Magnetic Surgical System Devices (Product Code PNL)
About Product Code PNL - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code PNL since 2016, with 7 receiving FDA clearance (average review time: 182 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under PNL have taken an average of 72 days to reach a decision - down from 218 days historically, suggesting improved FDA processing for this classification.
PNL devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →