Home / 510(k) Clearances / K212505

510(k) K212505

DUMI ManipulatOR by The O R Company Pty, Ltd. — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2022
Date Received
August 9, 2021
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.

  • K220202 — Uterine ElevatOR PRO with OccludOR Balloon (March 31, 2022)

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)
  • K181770 — Intrauterine Access Balloon Catheter, Selective Salpingography Catheter (March 29, 2019)
  • K180300 — Margolin HSG Cannula, Goldstein Sonohysterography Catheter (October 26, 2018)