Anesthesiology
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- ChemistryReview Panel
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- Ear, Nose, ThroatReview Panel
- MiscellaneousMiscellaneous
- ESIPolymer, Natural-Absorbable Gelatin Material3Product Code
- EWDProtector, Hearing (Insert)UProduct Code
- EWEProtector, Hearing (Circumaural)UProduct Code
- LEZAids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)UProduct Code
- LFAAids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)UProduct Code
- LFBButton, Nasal SeptalUProduct Code
- LRAHearing Aid, TactileUProduct Code
- LXVApparatus, Vestibular AnalysisUProduct Code
- MCMImplant, Cochlear3Product Code
- MHEImplant, Auditory Brainstem3Product Code
- MJVDevice, Inflation, Middle EarUProduct Code
- MPVImplant, Hearing, Active, Middle Ear, Partially Implanted3Product Code
- MRKSystem, Imaging, Fluorescence3Product Code
- QNUTranscutaneous Electrical Nerve Stimulator For The Relief Of Congestion2Product Code
- OAAAid, Visual, For NauseaNProduct Code
- QLVField Generator Positioning Device1Product Code
- EPGStimulator, Transdermal3Product Code
- OAFImplant, Hearing, Active, Middle Ear, Totally Implanted3Product Code
- OAQElectronic Media, HyperacusisNProduct Code
- OWODrug-Eluting Sinus Stent3Product Code
- PGQCochlear Implant With Combined Electrical Stimulation And Acoustic Amplification3Product Code
- QJATympanostomy Tube Delivery Product With Drug3Product Code
- QOOVentilator Tubing And AccessoriesNProduct Code
- QOPRespiratory Humidifier For Emergency UseNProduct Code
- QOSContinuous VentilatorNProduct Code
- QOTEmergency VentilatorNProduct Code
- QOVCritical Care VentilatorNProduct Code
- QOXMulti-Patient Circuit ConnectorNProduct Code
- QQGOropharyngeal Electrical Stimulator2Product Code
- QVNCombined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus2Product Code
- QXGCooperative Powered Surgical Assist Device For Ent Surgery2Product Code
- QZCExternal Mechanical Stimulator For The Relief Of Congestion2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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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
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
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.