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510(k) K221965

FemDx FalloView by Femdx Medsystems, Inc. — Product Code MKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2023
Date Received
July 5, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Falloposcope
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type

Other clearances for product code MKO

  • K974028 — STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING (January 21, 1998)
  • K963580 — IMAGYN FALLOPOSCOPY SYSTEM (January 31, 1997)
  • K962587 — CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM (January 31, 1997)