NJZ · Class I — Low Risk (general controls) · General, Plastic Surgery · 21 CFR 878.4800
Classification
FDA Product Code
NJZ
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 878.4800
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
The device is a vein extractor that is pushed through the leg around the vein to effect saphenous vein harvesting. It is like a long apple corer, but instead of taking out the apple core you are taking our someone's saphenous vein.