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Micrus Microcoil System

by Micrus Corp.

510(k) K032872

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 NumberK032872 Date28 Nov 2003ClearedStatusActive

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  • Withdrawn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
HCG
Device Class
Class II
Regulation
21 CFR Part 882.5950
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Micrus Microcoil System is a neurovascular embolization device designed for the endovascular treatment of intracranial aneurysms. It is also indicated for the management of other neurovascular abnormalities, including arteriovenous malformations and arteriovenous fistulae, as well as arterial and venous embolizations within the peripheral vasculature.

The system consists of an embolic coil attached to a delivery mechanism. This device has received FDA 510(k) clearance.

Other devices from Micrus Corp.

Questions

AI-generated answers, 21 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 is the primary clinical use of the Micrus Microcoil System?

    This device is indicated for the endovascular treatment of intracranial aneurysms. It is also used for the management of other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae, as well as for arterial and venous embolizations within the peripheral vasculature.

  • How is the Micrus Microcoil System configured for use?

    The system is designed as an integrated unit consisting of an embolic coil that is physically attached to a delivery mechanism, allowing for controlled placement during endovascular procedures.

  • Has this device received regulatory authorization?

    Yes, the Micrus Microcoil System has received FDA 510(k) clearance, which indicates that the device has been determined to be substantially equivalent to other legally marketed devices for its intended use.