510(k) K060908

SONOHYSTEROGRAPHY BIOPSY DEVICE by Cook Urological, Inc. — Product Code PGK

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 29, 2006
Date Received: April 3, 2006
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Cannula, Injector, Uterine, Endometrial Biopsy
Device Class: Class II
Regulation Number: 884.4530
Review Panel: OB
Submission Type

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

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510(k) K060908

Clearance Details

Device Classification

Other clearances by Cook Urological, Inc.

Other clearances for product code PGK