MKO · Class II · 21 CFR 884.1690

FDA Product Code MKO: Falloposcope

Leading manufacturers include Conceptus, Inc., Femdx Medsystems, Inc. and Imagyn Medical, Inc..

4
Total
4
Cleared
177d
Avg days
1997
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Falloposcope Devices (Product Code MKO)

4 devices
1–4 of 4
Cleared Mar 17, 2023
FemDx FalloView
K221965
Femdx Medsystems, Inc.
Obstetrics & Gynecology · 255d
Cleared Jan 21, 1998
STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING
K974028
Conceptus, Inc.
Obstetrics & Gynecology · 90d
Cleared Jan 31, 1997
CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM
K962587
Conceptus, Inc.
Obstetrics & Gynecology · 214d
Cleared Jan 31, 1997
IMAGYN FALLOPOSCOPY SYSTEM
K963580
Imagyn Medical, Inc.
Obstetrics & Gynecology · 147d

About Product Code MKO - Regulatory Context

510(k) Submission Activity

4 total 510(k) submissions under product code MKO since 1997, with 4 receiving FDA clearance (average review time: 177 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.