FDA product code MOV: Catheters, Salpingography
MOV is the FDA product code for catheters, salpingography. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 5 510(k) submissions under MOV, from 5 different applicants. The average 510(k) review took 553 days (median 851). FDA has posted 3 recalls for MOV devices.
Classification
| Field | Value |
|---|---|
| Device name | Catheters, Salpingography |
| Device class | Class II |
| Regulation | 21 CFR 884.4530 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MOV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 133 |
Compare with all 510(k) review times · Search every MOV clearance
Top MOV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook Incorporated | 1 | 2018-07-12 |
| Echocath, Inc. | 1 | 1995-11-16 |
| Ovamed Corp. | 1 | 1995-07-28 |
| Conceptus, Inc. | 1 | 1995-07-28 |
| Cook Ob/Gyn | 1 | 1995-07-28 |
Most recent MOV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K180552 | Cook Incorporated | Modified Novy Cornual Cannulation Set | 2018-07-12 | 133 |
| K932436 | Echocath, Inc. | ECHOMARK INTRAUTERINE GUIDING CATHETER | 1995-11-16 | 911 |
| K953314 | Conceptus, Inc. | CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM | 1995-07-28 | 16 |
| K931534 | Ovamed Corp. | OVAMED INTRAUTERINE ACCESS CATHETER | 1995-07-28 | 851 |
| K931476 | Cook Ob/Gyn | NOVY CORNUAL CANNULATION SET | 1995-07-28 | 856 |
Recalls for MOV devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-04-15.
Frequently asked questions
What is FDA product code MOV?
MOV is the FDA product code for catheters, salpingography. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is MOV?
Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k).
How long does a 510(k) take for product code MOV?
Across 5 cleared submissions the average was 553 days from receipt to decision (median 851).
Which companies have the most MOV clearances?
Cook Incorporated (1); Echocath, Inc. (1); Ovamed Corp. (1); Conceptus, Inc. (1); Cook Ob/Gyn (1).
Have MOV devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2016-04-15.
Next steps
- Run an FDA pathway report with predicate devices for product code MOV
- Run a recall and safety report across every MOV manufacturer
- Watch product code MOV 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.
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