Home / 510(k) Clearances / K162064

510(k) K162064

CrossBay IVF Embryo Transfer Catheter Set by Crossbay Medical, Inc. — Product Code MQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2017
Date Received
July 26, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6110
Review Panel
OB
Submission Type

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)
  • K142545 — SonoFlow Sonohysterography and Sonohysterosalpingography Device (March 20, 2015)
  • K133144 — SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE (March 19, 2014)

Other clearances for product code MQF

  • K253354 — Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175 (February 12, 2026)
  • K243373 — Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - (July 23, 2025)
  • K240307 — VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) (August 16, 2024)
  • K231730 — FemaSeed Intratubal Insemination (September 22, 2023)
  • K220010 — Daylily Single Use Sterile Embryo Transfer Catheter (December 16, 2022)
  • K200248 — Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators (July 1, 2020)
  • K192540 — Kitazato ET Catheters (May 1, 2020)
  • K190522 — Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intr (November 14, 2019)
  • K191015 — Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Cat (May 17, 2019)
  • K180302 — Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, S (October 24, 2018)