Instrument, Surgical, Disposable

Device Code: 5707

Product Code(s): KDC

Device Classification Information

Device Type ID5707
Device NameInstrument, Surgical, Disposable
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 CodeKDC
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5707
DeviceInstrument, Surgical, Disposable
Product CodeKDC
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Surgical Instrument For General Use.
CFR Regulation Number878.4800 [🔎]
Device Problems
Adverse Event Without Identified Device Or Use Problem
59
Break
13
Device Packaging Compromised
7
Device Contamination With Chemical Or Other Material
3
Fracture
3
Detachment Of Device Component
2
Material Separation
2
Device Contaminated During Manufacture Or Shipping
1
Split
1
Defective Device
1
Packaging Problem
1
Torn Material
1
Component Falling
1
Migration Or Expulsion Of Device
1
Defective Component
1
Migration
1
Appropriate Term/Code Not Available
1
Total Device Problems 99
Recalls
Manufacturer Recall Class Date Posted
1
Ethicon, Inc.
II Sep-27-2016
TPLC Last Update: 2019-04-02 21:11:09

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