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510(k) K192534

CrossBay Endometrial Tissue Sampler (ETS) by Crossbay Medical — Product Code HHK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2020
Date Received
September 16, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curette, Suction, Endometrial (And Accessories)
Device Class
Class II
Regulation Number
884.1175
Review Panel
OB
Submission Type

Other clearances by Crossbay Medical

  • K201952 — CrossGlide ETS Plus (August 5, 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)
  • K133144 — SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE (March 19, 2014)

Other clearances for product code HHK

  • K251882 — Uterine Aspiration Set (October 16, 2025)
  • K240434 — RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) (September 25, 2024)
  • K201952 — CrossGlide ETS Plus (August 5, 2020)
  • K102847 — DISPOSABLE ENDOMETRIAL SUCTION CURETTE (April 14, 2011)
  • K092982 — THE PANPAC SUCTION CURETTE (July 26, 2010)
  • K051294 — FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 (December 21, 2005)
  • K040189 — ENDOMETRIAL SAMPLING SYRINGE (October 4, 2004)
  • K021876 — MAS WITH OR WITHOUT SYRINGE (April 8, 2003)
  • K020628 — CURELLE, PREFERRED CURELLE, CUTEQ 2.5 (May 24, 2002)
  • K001555 — SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 (August 2, 2000)