FDA Product Code QNM: Mountable Electromechanical Surgical System For Transluminal Approaches
A Mountable Electromechanical Surgical System For Transluminal Approaches Is A Software-controlled, Patient Bed- And/or Operating Table-mounted Electromechanical Surgical System With Human/device Interfaces That Allows A Qualified User To Perform Transluminal Endoscopic Or Laparoscopic Surgical Procedures Using Surgical Instruments Attached To An Electromechanical Arm.
Leading manufacturers include Momentis Surgical , Ltd..
FDA 510(k) Cleared Mountable Electromechanical Surgical System For Transluminal Approaches Devices (Product Code QNM)
About Product Code QNM - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code QNM since 2021, with 7 receiving FDA clearance (average review time: 150 days).
Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QNM have taken an average of 78 days to reach a decision - down from 369 days historically, suggesting improved FDA processing for this classification.
QNM devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →