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510(k) K220202

Uterine ElevatOR PRO with OccludOR Balloon by The O R Company Pty, Ltd. — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2022
Date Received
January 24, 2022
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 The O R Company Pty, Ltd.

  • K212505 — DUMI ManipulatOR (January 10, 2022)

Other clearances for product code LKF

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  • 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)
  • 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)