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510(k) K231730

FemaSeed Intratubal Insemination by Femasys, Inc. — Product Code MQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2023
Date Received
June 13, 2023
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 Femasys, Inc.

  • K253403 — FemVue® Controlled Saline-Air Device (FSA-300) (December 15, 2025)
  • K242002 — FemVue MINI Saline-Air Device (November 22, 2024)
  • K241693 — FemChec Controlled Saline-Air Device (FCD-250) (September 6, 2024)
  • K122658 — FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-00 (December 20, 2012)
  • K110993 — FEMCHEC PRESSURE MANAGEMET DEVICE (October 12, 2011)
  • K110288 — FEMVUE SALINE-AIR DEVICE (April 28, 2011)
  • K100662 — FEMVUE CORNUAL BALLOON CATHETER (April 7, 2010)
  • K083690 — FEMVUE(TM) CATHETER SYSTEM (June 23, 2009)

Other clearances for product code MQF

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  • 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)
  • 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)
  • K173431 — Towako Transmyometrial Embryo Transfer Set (May 18, 2018)