Agents, Embolic, For Treatment Of Uterine Fibroids
Embolic Agents for Treatment of Uterine Fibroids are small particles or microspheres delivered via catheter into the uterine arteries to block blood flow to fibroid tumors, causing them to shrink in a procedure known as uterine fibroid embolization (UFE). These agents are implanted in the vasculature and remain in place. Classified as FDA Class 2, they require 510(k) premarket clearance under regulation 870.3300 (Cardiovascular specialty, reviewed by the Obstetrics/Gynecology panel). This device carries the implant flag.
Basic Information
- Product Code
- NAJ
- Device Class
- FDA class 2
- Regulation Number
- 870.3300
- Medical Specialty
- Cardiovascular
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233813 | Bearing nsPVA Express | Dec 21, 2023 | Substantially Equivalent | Merit Medical Systems, Inc. |
| K173871 | CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres | Sep 17, 2018 | Substantially Equivalent | Suzhou Hengrui Callisyn Biomedical Co., Ltd. |
| K133447 | EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES | Feb 24, 2014 | Substantially Equivalent | CELONOVA BIOSCIENCES, INC. |
| K130259 | BEARING NSPVA EMBOLIZATION PARTICLES | Jun 07, 2013 | Substantially Equivalent | MERIT MEDICAL SYSTEMS, INC. |
| K100663 | CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 | Apr 16, 2010 | Substantially Equivalent | Boston Scientific Corporation |
| K081768 | COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES | Dec 23, 2008 | Substantially Equivalent | COOK INCORPORATED |
| K030966 | CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER | Sep 23, 2003 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K021397 | EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION | Nov 22, 2002 | Substantially Equivalent | BIOSPHERE MEDICAL, INC. |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.