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Cooperative Powered Surgical Assist Device For Ent Surgery

Page Type
Product Code
Definition
A cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery is a device that facilitates ENT surgical procedures, including instrument placement. The device works in conjunction with the surgeon's movements to assist with precise and stable positioning of an instrument while maintaining the surgeon’s direct physical control of the instrument.
Physical State
A powered device that may contain a motor and other hardware, in addition to software to assist in surgical procedures by holding a manual surgical tool in 3D space and allowing it to be positioned by the surgeon when/where desired.
Technical Method
Holds a manual surgical tool and allows it to be positioned under direct surgeon control.
Target Area
Ear, Nose and Throat
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
874.4460
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QXG is linked to regulation 21CFR874.4460, which does not seem to exist yet. It may be pending at the moment.

Cooperative Powered Surgical Assist Device For Ent Surgery

Page Type
Product Code
Definition
A cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery is a device that facilitates ENT surgical procedures, including instrument placement. The device works in conjunction with the surgeon's movements to assist with precise and stable positioning of an instrument while maintaining the surgeon’s direct physical control of the instrument.
Physical State
A powered device that may contain a motor and other hardware, in addition to software to assist in surgical procedures by holding a manual surgical tool in 3D space and allowing it to be positioned by the surgeon when/where desired.
Technical Method
Holds a manual surgical tool and allows it to be positioned under direct surgeon control.
Target Area
Ear, Nose and Throat
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
874.4460
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QXG is linked to regulation 21CFR874.4460, which does not seem to exist yet. It may be pending at the moment.