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EmboCube Embolization Gelatin

by Biosphere Medical, S.A. 2 variants

510(k) K181021

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181021 Date27 Sep 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
KRD
Device Class
Class II
Regulation
21 CFR Part 870.3300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

The EmboCube Embolization Gelatin is a medical device used for embolization, consisting of pre-cut, dry cubes of resorbable gelatin sponge. It is designed to promote embolization in blood vessels, and is indicated for use in embolization of hypervascular tumors and to occlude blood flow to control bleeding or hemorrhaging in the peripheral vasculature.

The EmboCube Embolization Gelatin is supplied in a syringe, pre-loaded with uniformly cut gelatin foam, and is available in 2 cube sizes and 3 weight configurations. It is a single-use, sterile device, and its use is regulated under the product code KRD, with a regulation number of 870.3300.

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