Forceps, Wire Holding

Device Code: 5687

Product Code(s): HYA

Device Classification Information

Device Type ID5687
Device NameForceps, Wire Holding
Regulation DescriptionManual Surgical Instrument For General Use.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch Two - Surgical (GSDB2)
Submission Type510(K) Exempt
CFR Regulation Number878.4800 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHYA
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5687
DeviceForceps, Wire Holding
Product CodeHYA
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Surgical Instrument For General Use.
CFR Regulation Number878.4800 [🔎]
Device Problems
Fracture
3
Adverse Event Without Identified Device Or Use Problem
1
Total Device Problems 4
Recalls
Manufacturer Recall Class Date Posted
1
Biomet, Inc.
II Jul-14-2015
TPLC Last Update: 2019-04-02 21:10:50

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