Instrument, Clip Forming/cutting

Device Code: 3715

Product Code(s): HBS

Device Classification Information

Device Type ID3715
Device NameInstrument, Clip Forming/cutting
Regulation DescriptionClip Forming/cutting Instrument.
Regulation Medical SpecialtyNeurology
Review PanelNeurology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Neurodiagnostic And Neurosurgical Devices Branch (NDNB)
Submission Type510(K) Exempt
CFR Regulation Number882.4190 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHBS
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3715
DeviceInstrument, Clip Forming/cutting
Product CodeHBS
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionClip Forming/cutting Instrument.
CFR Regulation Number882.4190 [🔎]
Device Problems
Overheating Of Device
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 20:35:14

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