510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NAJClass II

Agents, Embolic, For Treatment Of Uterine Fibroids

21 CFR 870.3300 / Cardiovascular
FDA source (opens on fda.gov)

NAJ is the FDA product code for Agents, Embolic, For Treatment Of Uterine Fibroids, a class II device type, regulated under 21 CFR 870.3300. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
NAJ
Device name
Agents, Embolic, For Treatment Of Uterine Fibroids
Regulation
21 CFR 870.3300
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
1

Clearances, product code NAJ

By decision year
8 clearances under product code NAJ with a decision year between 2002 and 2023, 2002 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NAJ by decision year
YearClearances
20021
20031
20081
20101
20131
20141
20181
20231

Applicants with the most clearances

Product code NAJ
Applicants holding the most 510(k) clearances under product code NAJ
ApplicantClearances
Boston Scientific Corporation2
Merit Medical Systems, Inc.2
Biosphere Medical, S.A.1
Celonova Biosciences, Inc.1
Cook Incorporated1
Suzhou Hengrui Callisyn Biomedical Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order