Home / 510(k) Clearances / K992307

510(k) K992307

EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER by Fertility Technology Resources, Inc. — Product Code MQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1999
Date Received
July 9, 1999
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 Fertility Technology Resources, Inc.

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  • K032208 — MONA LISA ASPIRATION NEEDLE (December 9, 2003)
  • K023017 — TUCKER EMBRYO CATHETER (December 13, 2002)

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  • K231730 — FemaSeed Intratubal Insemination (September 22, 2023)
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  • 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)