MKO — Falloposcope Class II

FDA Device Classification

Classification Details

Product Code
MKO
Device Class
Class II
Regulation Number
884.1690
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K221965femdx medsystemsFemDx FalloViewMarch 17, 2023
K974028conceptusSTARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBINGJanuary 21, 1998
K963580imagyn medicalIMAGYN FALLOPOSCOPY SYSTEMJanuary 31, 1997
K962587conceptusCONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEMJanuary 31, 1997