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510(k) K041470

MORTON IUI CATHETERS by Fertility Technology Resources, Inc. — Product Code MQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2004
Date Received
June 2, 2004
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.

  • K032208 — MONA LISA ASPIRATION NEEDLE (December 9, 2003)
  • K023017 — TUCKER EMBRYO CATHETER (December 13, 2002)
  • K992307 — EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CA (September 13, 1999)

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  • K180302 — Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, S (October 24, 2018)