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510(k) K222798

Rejoni Intrauterine Catheter by Rejoni, Inc. — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2022
Date Received
September 16, 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

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  • K241693 — FemChec Controlled Saline-Air Device (FCD-250) (September 6, 2024)
  • K223064 — ALLY II Uterine Positioning System™ (UPS) (October 28, 2022)
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  • 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)