PGK · Class II · 21 CFR 884.4530

FDA Product Code PGK: Cannula, Injector, Uterine, Endometrial Biopsy

To Deliver Saline And/or Contrast Media To Complete Saline Infusion Sonohysterography And/or Hysterosalpingogram Respectively And To Obtain Endometrial Biopsy

Leading manufacturers include Cook Urological, Inc. and Crossbay Medical, Inc..

2
Total
2
Cleared
120d
Avg days
2006
Since

FDA 510(k) Cleared Cannula, Injector, Uterine, Endometrial Biopsy Devices (Product Code PGK)

2 devices
1–2 of 2
Cleared Mar 19, 2014
SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE
K133144
Crossbay Medical, Inc.
Obstetrics & Gynecology · 153d
Cleared Jun 29, 2006
SONOHYSTEROGRAPHY BIOPSY DEVICE
K060908
Cook Urological, Inc.
Obstetrics & Gynecology · 87d

About Product Code PGK - Regulatory Context