Stripper, Vein, Reusable

Device Code: 5591

Product Code(s): GAI

Device Classification Information

Device Type ID5591
Device NameStripper, Vein, Reusable
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 One - Light Based/Laser (GSDB1)
Submission Type510(K) Exempt
CFR Regulation Number878.4800 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGAI
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5591
DeviceStripper, Vein, Reusable
Product CodeGAI
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Surgical Instrument For General Use.
CFR Regulation Number878.4800 [🔎]
Device Problems
Fracture
5
Break
4
Detachment Of Device Or Device Component
1
Total Device Problems 10
TPLC Last Update: 2019-04-02 21:09:03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.