PGK — Cannula, Injector, Uterine, Endometrial Biopsy Class II

FDA Device Classification

Classification Details

Product Code: PGK
Device Class: Class II
Regulation Number: 884.4530
Submission Type
Review Panel: OB
Medical Specialty: Obstetrics/Gynecology
Implant: No

Definition

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

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K133144	crossbay medical	SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE	March 19, 2014
K060908	cook urological	SONOHYSTEROGRAPHY BIOPSY DEVICE	June 29, 2006