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510(k) K133144

SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE by Crossbay Medical, Inc. — Product Code PGK

K133144 is an FDA 510(k) premarket notification submitted by Crossbay Medical, Inc. for the device "SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE". The FDA issued a decision of Substantially Equivalent on March 19, 2014. The device falls under product code PGK (Cannula, Injector, Uterine, Endometrial Biopsy), a Class II device regulated under 21 CFR 884.4530. Crossbay Medical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2014
Date Received
October 17, 2013
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

Other clearances by Crossbay Medical, Inc.

  • K201952 — CrossGlide ETS Plus (August 5, 2020)
  • K192534 — CrossBay Endometrial Tissue Sampler (ETS) (March 25, 2020)
  • K190813 — CrossBay Cervical Dilator Catheter System (August 23, 2019)
  • K162064 — CrossBay IVF Embryo Transfer Catheter Set (January 5, 2017)
  • K142545 — SonoFlow Sonohysterography and Sonohysterosalpingography Device (March 20, 2015)

Other clearances for product code PGK

  • K060908 — SONOHYSTEROGRAPHY BIOPSY DEVICE (June 29, 2006)

FDA data resources