K190006 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 April 29, 2019, 117 days after receiving the submission on January 2, 2019.
This device falls under the Gastroenterology & Urology 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 | K190006 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2019 |
| Decision Date | April 29, 2019 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| 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. |