FDA product code NAJ: Agents, Embolic, For Treatment Of Uterine Fibroids
NAJ is the FDA product code for agents, embolic, for treatment of uterine fibroids. It is a Class II device, regulated under 21 CFR 870.3300 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 8 510(k) submissions under NAJ, 1 in the last five years, from 7 different applicants. The average 510(k) review took 141 days (median 153). FDA has posted 1 recall for NAJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Agents, Embolic, For Treatment Of Uterine Fibroids |
| Device class | Class II |
| Regulation | 21 CFR 870.3300 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for NAJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 271 |
| 2023 | 1 | 21 |
Compare with all 510(k) review times · Search every NAJ clearance
Top NAJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Merit Medical Systems, Inc. | 2 | 2023-12-21 |
| Suzhou Hengrui Callisyn Biomedical Co., Ltd. | 1 | 2018-09-17 |
| Celonova Biosciences, Inc. | 1 | 2014-02-24 |
| Boston Scientific Corporation | 1 | 2010-04-16 |
| Cook Incorporated | 1 | 2008-12-23 |
2 more applicants have NAJ clearances. See the full list in Caduvo.
Most recent NAJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233813 | Merit Medical Systems, Inc. | Bearing nsPVA Express | 2023-12-21 | 21 |
| K173871 | Suzhou Hengrui Callisyn Biomedical Co., Ltd. | CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres | 2018-09-17 | 271 |
| K133447 | Celonova Biosciences, Inc. | EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES | 2014-02-24 | 104 |
| K130259 | Merit Medical Systems, Inc. | BEARING NSPVA EMBOLIZATION PARTICLES | 2013-06-07 | 126 |
| K100663 | Boston Scientific Corporation | CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 | 2010-04-16 | 39 |
Recalls for NAJ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-08-17.
Frequently asked questions
What is FDA product code NAJ?
NAJ is the FDA product code for agents, embolic, for treatment of uterine fibroids. It is a Class II device, regulated under 21 CFR 870.3300 and reviewed by the Obstetrics and Gynecology panel.
What device class is NAJ?
Class II, regulation 21 CFR 870.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code NAJ?
Across 8 cleared submissions the average was 141 days from receipt to decision (median 153).
Which companies have the most NAJ clearances?
Merit Medical Systems, Inc. (2); Suzhou Hengrui Callisyn Biomedical Co., Ltd. (1); Celonova Biosciences, Inc. (1); Boston Scientific Corporation (1); Cook Incorporated (1).
Have NAJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2009-08-17.
Next steps
- Run an FDA pathway report with predicate devices for product code NAJ
- Run a recall and safety report across every NAJ manufacturer
- Watch product code NAJ 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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