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510(k) K242002

FemVue MINI Saline-Air Device by Femasys, Inc. — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2024
Date Received
July 9, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Manipulator/Injector, Uterine
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Femasys, Inc.

  • K253403 — FemVue® Controlled Saline-Air Device (FSA-300) (December 15, 2025)
  • K241693 — FemChec Controlled Saline-Air Device (FCD-250) (September 6, 2024)
  • K231730 — FemaSeed Intratubal Insemination (September 22, 2023)
  • 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 LKF

  • K253403 — FemVue® Controlled Saline-Air Device (FSA-300) (December 15, 2025)
  • K252260 — RELIEEV HSG Catheter (HSG7FA1) (November 26, 2025)
  • K240364 — RELIEEV Uterine Manipulator Injector (CUMI 5.0) (October 16, 2024)
  • K241693 — FemChec Controlled Saline-Air Device (FCD-250) (September 6, 2024)
  • K222798 — Rejoni Intrauterine Catheter (December 16, 2022)
  • K223064 — ALLY II Uterine Positioning System™ (UPS) (October 28, 2022)
  • K220202 — Uterine ElevatOR PRO with OccludOR Balloon (March 31, 2022)
  • K212505 — DUMI ManipulatOR (January 10, 2022)
  • K181770 — Intrauterine Access Balloon Catheter, Selective Salpingography Catheter (March 29, 2019)
  • K180300 — Margolin HSG Cannula, Goldstein Sonohysterography Catheter (October 26, 2018)