Product Code: FOD FDA class 1 21 CFR 880.5950

Device, Occlusion, Umbilical

General Hospital

The Umbilical Occlusion Device is used to clamp or ligate the umbilical cord of a newborn after birth, preventing blood loss and facilitating cord separation. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FOD, regulated under 21 CFR 880.5950 in the General Hospital specialty.

510(k)s
0
FEI Numbers
56
Registration Numbers
56
Unique Applicants
0
Years Active

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Basic Information

Product Code
FOD
Device Class
FDA class 1
Regulation Number
880.5950
Medical Specialty
General Hospital
Review Panel
HO
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 56 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 56 registration numbers. Click on an entry to view related FDA registrations.