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510(k) K931122

OVAMED HSG CATHETER by Ovamed Corp. — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1995
Date Received
March 4, 1993
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 Ovamed Corp.

  • K951946 — HYSTEROSYS FLEXIBLE HYSTEROCOPE (November 20, 1995)
  • K931534 — OVAMED INTRAUTERINE ACCESS CATHETER (July 28, 1995)
  • K931167 — OVAMED FALLOPIAN OSTIAL ACCESS CATHETER (June 22, 1995)
  • K943593 — SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM (March 22, 1995)

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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)
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  • K212505 — DUMI ManipulatOR (January 10, 2022)
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