Instrument, Vitreous Aspiration And Cutting, Battery-powered

Device Code: 4174

Product Code(s): HKP

Device Classification Information

Device Type ID4174
Device NameInstrument, Vitreous Aspiration And Cutting, Battery-powered
Regulation DescriptionVitreous Aspiration And Cutting Instrument.
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 Number886.4150 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHKP
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID4174
DeviceInstrument, Vitreous Aspiration And Cutting, Battery-powered
Product CodeHKP
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionVitreous Aspiration And Cutting Instrument.
CFR Regulation Number886.4150 [🔎]
TPLC Last Update: 2019-04-02 20:44:12

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