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510(k) Data Aggregation
K Number
K133144Device Name
SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE
Manufacturer
CrossBay Medical, Inc.
Date Cleared
2014-03-19
(153 days)
Product Code
PGK, HFE
Regulation Number
884.4530Why did this record match?
Product Code :
PGK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CrossBay SonsoSure Sonohysterography and Endometrial Sampling Device is indicated for use to access the uterine cavity for saline infusion sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device.
Device Description
The CrossBay Medical SonoSure Device is a catheter that enables saline infusion sonohysterography procedures and endometrial biopsy collection within a single device. The catheter is comprised of standard polymer materials and contains a silicone acorn tip to enable a cervical seal. The distal end of the device contains a retractable nylon brush for endometrial biopsy sampling. The distal end of the device contains an empty PVC bag that can be filled with saline. The device is provided sterile and is intended for single use only.
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K Number
K060908Device Name
SONOHYSTEROGRAPHY BIOPSY DEVICE
Manufacturer
COOK UROLOGICAL, INC.
Date Cleared
2006-06-29
(87 days)
Product Code
PGK, HFF
Regulation Number
884.4530Why did this record match?
Product Code :
PGK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cook® Sonohysterography Biopsy Catheter is used to access the uterine cavily for sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device. The device is a single catheter designed to perform saline infusion sonohysterography then, if indicated, biopsy of the endometrium using the same device. The device will be supplied sterile and is intended for one time use.
Device Description
The Cook® Sonohysterography Biopsy Catheter is used to access the uterine cavity for sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device. The device is a single catheter designed to perform saline infusion sonohysterography then, if indicated, biopsy of the endometrium using the same device. The device will be supplied sterile and is intended for one time use. The materials used in the construction of the Cook® Sonohysterography Biopsy Device are well known in the medical field. Biocompatibility, Ethylene Oxide Residual, and Functional testing have shown that the materials and the device meet the test requirements and are safe and effective. Literary articles prove the usefulness of this type of device to the clinician and patient population.
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