DEN230084 is an FDA 510(k) submission for the Dexter L6 System. This device is classified as a Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field (Class II - Special Controls, product code SDD).
Submitted by Distalmotion SA (Epalinges, CH). The FDA issued a Not Cleared (DENG) decision on October 25, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4965. An Electromechanical Surgical System With Transient Sterile Field Presence Of Both Surgeon And Primary Control Interface Is A Software-controlled Electromechanical System With Fully Positionable Patient/device Interfaces Which Allows A Qualified User To Perform Surgical Techniques During Minimally Invasive Surgical Procedures. The Device Allows For Both The Surgeon And Primary Control Interface To Have Presence Inside The Sterile Field As Needed Within The Clinical Context Of Use..
| 510(k) Number | DEN230084 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 15, 2023 |
| Decision Date | October 25, 2024 |
| Days to Decision | 315 days |
| Submission Type | Direct |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | SDD - Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4965 |
| Definition | An Electromechanical Surgical System With Transient Sterile Field Presence Of Both Surgeon And Primary Control Interface Is A Software-controlled Electromechanical System With Fully Positionable Patient/device Interfaces Which Allows A Qualified User To Perform Surgical Techniques During Minimally Invasive Surgical Procedures. The Device Allows For Both The Surgeon And Primary Control Interface To Have Presence Inside The Sterile Field As Needed Within The Clinical Context Of Use. |