510(k) K223673
K223673 is an FDA 510(k) premarket notification submitted by Levita Magnetics International Corp for the device "Surgeon Controlled Arm". The FDA issued a decision of Substantially Equivalent on Aug 4, 2023. The device falls under product code PNL (Magnetic Surgical System), a Class II device regulated under 21 CFR 878.4815. Levita Magnetics International Corp has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 4, 2023
- Date Received
- Dec 7, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Magnetic Surgical System
- Device Class
- Class II
- Regulation Number
- 878.4815
- Review Panel
- SU
- Submission Type
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.