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510(k) K083690

FEMVUE(TM) CATHETER SYSTEM by Femasys, Inc. — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2009
Date Received
December 12, 2008
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)
  • K242002 — FemVue MINI Saline-Air Device (November 22, 2024)
  • 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)

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)
  • K242002 — FemVue MINI Saline-Air Device (November 22, 2024)
  • 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)