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CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres

by Suzhou Hengrui Callisyn Biomedical Co., Ltd.

510(k) K173871

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK173871 Date17 Sep 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NAJ
Device Class
Class II
Regulation
21 CFR Part 870.3300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

CalliSpheres Embolic Microspheres and 8Spheres Embolic Microspheres are embolic agents indicated for the treatment of uterine fibroids. These devices are designed to function as embolic agents within the cardiovascular system.

This device is identified under FDA 510(k) number K173871. It is classified as a class 2 medical device under regulation number 870.3300.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are CalliSpheres and 8Spheres Embolic Microspheres used for?

    These devices are indicated for the treatment of uterine fibroids. They function as embolic agents designed for use within the cardiovascular system.

  • What is the regulatory status of these embolic microspheres?

    These devices are identified under FDA 510(k) number K173871. They are classified as class 2 medical devices under regulation number 870.3300.

  • Who is the manufacturer of these embolic agents?

    CalliSpheres and 8Spheres Embolic Microspheres are manufactured by Suzhou Hengrui Callisyn Biomedical Co., Ltd., located in Suzhou, China.