Product code PGK

Device name

Cannula, Injector, Uterine, Endometrial Biopsy

Medical specialty

Obstetrics/Gynecology

Device class

2

Regulation number

884.4530

Review panel

OB

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

to deliver saline and/or contrast media to complete saline infusion sonohysterography and/or hysterosalpingogram respectively and to obtain endometrial biopsy

Source

FDA openFDA device classification dataset