PGK

Cannula, Injector, Uterine, Endometrial Biopsy

Product code

PGK

Device name

Cannula, Injector, Uterine, Endometrial Biopsy

Device class

Class 2

21 CFR

21 CFR 884.4530

Medical specialty

Obstetrics/Gynecology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).