Home / 510(k) Clearances / K150519

510(k) K150519

ManipulatOR PRO, ManipulatOR by Gynetech Pty. , Ltd. — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2015
Date Received
March 2, 2015
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 Gynetech Pty. , Ltd.

  • K142700 — InsufflatOR Needle (December 19, 2014)
  • K142164 — MANIPULATOR; MANIPULATOR PRO (December 17, 2014)
  • K051594 — MCCARTNEY ACCESS TUBE (September 2, 2005)

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)