Saw, Electrically Powered

Device Code: 5492

Product Code(s): DWI

Device Classification Information

Device Type ID5492
Device NameSaw, Electrically Powered
Regulation DescriptionSurgical Instrument Motors And Accessories/attachments.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1)
Submission Type510(K) Exempt
CFR Regulation Number878.4820 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeDWI
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5492
DeviceSaw, Electrically Powered
Product CodeDWI
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionSurgical Instrument Motors And Accessories/attachments.
CFR Regulation Number878.4820 [🔎]
Device Problems
Break
5
Total Device Problems 5
TPLC Last Update: 2019-04-02 21:07:09

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