Home / 510(k) Clearances / K173871

510(k) K173871

CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres by Suzhou Hengrui Callisyn Biomedical Co., Ltd. — Product Code NAJ

K173871 is an FDA 510(k) premarket notification submitted by Suzhou Hengrui Callisyn Biomedical Co., Ltd. for the device "CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres". The FDA issued a decision of Substantially Equivalent on September 17, 2018. The device falls under product code NAJ (Agents, Embolic, For Treatment Of Uterine Fibroids), a Class II device regulated under 21 CFR 870.3300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2018
Date Received
December 20, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agents, Embolic, For Treatment Of Uterine Fibroids
Device Class
Class II
Regulation Number
870.3300
Review Panel
OB
Submission Type

Other clearances for product code NAJ

  • K233813 — Bearing nsPVA Express™ (December 21, 2023)
  • K133447 — EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES (February 24, 2014)
  • K130259 — BEARING NSPVA EMBOLIZATION PARTICLES (June 7, 2013)
  • K100663 — CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 (April 16, 2010)
  • K081768 — COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES (December 23, 2008)
  • K030966 — CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER (September 23, 2003)
  • K021397 — EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMB (November 22, 2002)

FDA data resources