DeviceClearance

Product code PGK— Obstetrics/Gynecology

SONOHYSTEROGRAPHY BIOPSY DEVICE

Classification name
Cannula, Injector, Uterine, Endometrial Biopsy
Device class
Class 2
Regulation
21 CFR 884.4530
Advisory panel
Obstetrics/Gynecology
Total cleared
2
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code PGK under 21 CFR 884.4530, via openFDA

Market context for product code PGK

FDA has cleared 2 devices under product code PGK between 2006 and 2014, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PGK

Recent clearances under product code PGK

Data sourced from openFDA. This site is unofficial and independent of the FDA.