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510(k) K181770

Intrauterine Access Balloon Catheter, Selective Salpingography Catheter by Cook Incorporated — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2019
Date Received
July 3, 2018
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

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  • 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)
  • K180300 — Margolin HSG Cannula, Goldstein Sonohysterography Catheter (October 26, 2018)