Home / 510(k) Clearances / K221965

510(k) K221965

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

K221965 is an FDA 510(k) premarket notification submitted by Femdx Medsystems, Inc. for the device "FemDx FalloView". The FDA issued a decision of Substantially Equivalent on March 17, 2023. The device falls under product code MKO (Falloposcope), a Class II device regulated under 21 CFR 884.1690.

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)

FDA data resources