FDA Product Code NAJ: Agents, Embolic, For Treatment Of Uterine Fibroids
Leading manufacturers include Boston Scientific Corp, Boston Scientific Corporation and Suzhou Hengrui Callisyn Biomedical Co., Ltd..
8
Total
8
Cleared
141d
Avg days
2002
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Agents, Embolic, For Treatment Of Uterine Fibroids Devices (Product Code NAJ)
8 devices
Cleared
Dec 21, 2023
Bearing nsPVA Express™
Merit Medical Systems, Inc.
Obstetrics & Gynecology
21d
Cleared
Sep 17, 2018
CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
Suzhou Hengrui Callisyn Biomedical Co., Ltd.
Obstetrics & Gynecology
271d
Cleared
Apr 16, 2010
CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
Boston Scientific Corporation
Obstetrics & Gynecology
39d
Cleared
Sep 23, 2003
CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER
Boston Scientific Corp
Obstetrics & Gynecology
180d
About Product Code NAJ - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code NAJ since 2002, with 8 receiving FDA clearance (average review time: 141 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.