DEN150007 is an FDA 510(k) submission for the Magnetic Surgical System. This device is classified as a Magnetic Surgical System (Class II - Special Controls, product code PNL).
Submitted by Levita Magnetics International Corp (San Mateo, US). The FDA issued a Not Cleared (DENG) decision on June 13, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 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..
| 510(k) Number | DEN150007 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | February 10, 2015 |
| Decision Date | June 13, 2016 |
| Days to Decision | 489 days |
| Submission Type | Direct |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | PNL - Magnetic Surgical System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4815 |
| 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. |