MKOClass II

Falloposcope

21 CFR 884.1690 / Obstetrics/Gynecology

MKO is the FDA product code for Falloposcope, a class II device type, regulated under 21 CFR 884.1690. As of 2026-09-10, FDA records hold 4 510(k) clearances under this code, the most recent dated 2023-03-17, and no recalls.

Classification record

Product code: MKO
Device name: Falloposcope
Regulation: 21 CFR 884.1690
Device class: Class II
Review panel: Obstetrics/Gynecology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 4
Ingested recalls: 0

Clearances, product code MKO

By decision year

4 clearances under product code MKO with a decision year between 1997 and 2023, 1997 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code MKO by decision year
Year	Clearances
1997	2
1998	1
2023	1

Applicants with the most clearances

Product code MKO

Applicants holding the most 510(k) clearances under product code MKO
Applicant	Clearances
Conceptus, Inc.	2
Femdx Medsystems, Inc.	1
Imagyn Medical, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code MKO.

Recent clearances

Product code MKO

Recent recalls

Product code MKO

FDA records show no recalls under product code MKO.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)