Apparatus, Cautery, Radiofrequency, Battery-powered

Device Code: 4304

Product Code(s): HQQ

Device Classification Information

Device Type ID4304
Device NameApparatus, Cautery, Radiofrequency, Battery-powered
Regulation DescriptionRadiofrequency Electrosurgical Cautery Apparatus.
Regulation Medical SpecialtyOphthalmic
Review PanelOphthalmic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Diagnostic And Surgical Devices Branch (DSDB)
Submission Type510(k)
CFR Regulation Number886.4100 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHQQ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID4304
DeviceApparatus, Cautery, Radiofrequency, Battery-powered
Product CodeHQQ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionRadiofrequency Electrosurgical Cautery Apparatus.
CFR Regulation Number886.4100 [🔎]
TPLC Last Update: 2019-04-02 20:46:40

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