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QNMClass II

Mountable Electromechanical Surgical System For Transluminal Approaches

21 CFR 878.4961 / General, Plastic Surgery

QNM is the FDA product code for Mountable Electromechanical Surgical System For Transluminal Approaches, a class II device type, regulated under 21 CFR 878.4961. FDA's definition for this code reads: "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...". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QNM
Device name
Mountable Electromechanical Surgical System For Transluminal Approaches
FDA definition
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.
Regulation
21 CFR 878.4961
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code QNM

By decision year
8 clearances under product code QNM with a decision year between 2021 and 2025, 2025 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code QNM by decision year
YearClearances
20211
20231
20242
20254

Applicants with the most clearances

Product code QNM
Applicants holding the most 510(k) clearances under product code QNM
ApplicantClearances
Momentis Surgical Ltd.8

Companies listing this code with FDA

Companies whose registered establishments list this code