FDA product code MKO: Falloposcope
MKO is the FDA product code for falloposcope. It is a Class II device, regulated under 21 CFR 884.1690 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 4 510(k) submissions under MKO, 1 in the last five years, from 3 different applicants. The average 510(k) review took 176 days (median 180).
Classification
| Field | Value |
|---|---|
| Device name | Falloposcope |
| Device class | Class II |
| Regulation | 21 CFR 884.1690 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for MKO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 255 |
Compare with all 510(k) review times · Search every MKO clearance
Top MKO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Conceptus, Inc. | 2 | 1998-01-21 |
| Femdx Medsystems, Inc. | 1 | 2023-03-17 |
| Imagyn Medical, Inc. | 1 | 1997-01-31 |
Most recent MKO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221965 | Femdx Medsystems, Inc. | FemDx FalloView | 2023-03-17 | 255 |
| K974028 | Conceptus, Inc. | STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING | 1998-01-21 | 90 |
| K962587 | Conceptus, Inc. | CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM | 1997-01-31 | 214 |
| K963580 | Imagyn Medical, Inc. | IMAGYN FALLOPOSCOPY SYSTEM | 1997-01-31 | 147 |
Recalls for MKO devices
openFDA lists no recalls for product code MKO.
Frequently asked questions
What is FDA product code MKO?
MKO is the FDA product code for falloposcope. It is a Class II device, regulated under 21 CFR 884.1690 and reviewed by the Obstetrics and Gynecology panel.
What device class is MKO?
Class II, regulation 21 CFR 884.1690. Typical premarket route: 510(k).
How long does a 510(k) take for product code MKO?
Across 4 cleared submissions the average was 176 days from receipt to decision (median 180).
Which companies have the most MKO clearances?
Conceptus, Inc. (2); Femdx Medsystems, Inc. (1); Imagyn Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MKO
- Run a recall and safety report across every MKO manufacturer
- Watch product code MKO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Obstetrics and Gynecology product codes · FDA product code lookup · 510(k) database search · 510(k) review times