K180894 is an FDA 510(k) clearance 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 Cleared decision on September 19, 2018, 167 days after receiving the submission on April 5, 2018.
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 | K180894 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2018 |
| Decision Date | September 19, 2018 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| 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. |