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

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K133144	SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE	Crossbay Medical, Inc.	2014-03-19
K060908	SONOHYSTEROGRAPHY BIOPSY DEVICE	Cook Urological, Inc.	2006-06-29

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