Product Code: GAI FDA class 1 21 CFR 878.4800

Stripper, Vein, Reusable

General, Plastic Surgery

The Stripper, Vein, Reusable (product code GAI) is a reusable surgical instrument used to remove varicose or other veins from the limbs by stripping them from surrounding tissue during general or plastic surgical procedures. It is classified as FDA Class 1, the lowest risk tier, subject only to general controls and not requiring premarket notification. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

510(k)s
0
FEI Numbers
51
Registration Numbers
51
Unique Applicants
0
Years Active

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Basic Information

Product Code
GAI
Device Class
FDA class 1
Regulation Number
878.4800
Medical Specialty
General, Plastic Surgery
Review Panel
SU
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

FEI Numbers

This FDA classification entry is associated with 51 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 51 registration numbers. Click on an entry to view related FDA registrations.